Clinical trial NCT02814916: Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
Official title: A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Methicillin-Resistant Staphylococcus Aureus
Bacterial Infections
Staphylococcal Skin Infections
Keywords: Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 199
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.


Eligibility criteria: Inclusion Criteria:

* Male or female patients birth to 17 years (inclusive)
* A clinical picture compatible with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) suspected or confirmed to be caused by Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA).
* In addition to local signs of ABSSSI, the patient has at least one of the following:
* Fever, defined as body temperature ≥ 38.4°C (101.2°F) taken orally, ≥ 38.7°C (101.6°F) tympanically, or ≥ 39°C (102.2°F) rectally (core temperature) OR
* Leukocytosis (WBC \> 10,000 mm3) or leukopenia (WBC \< 2,000 mm3) or left shift of \>10% band neutrophils
* Infection either involving deeper soft tissue or requiring significant surgical intervention
* Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which i. requires surgical incision and drainage, and ii. is associated with cellulitis such that the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR iii. alternatively, involves the central face and is associated with an area of erythema of at least 15 cm2 b. Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that: i. the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, involves the central face and is associated with an affected area of at least 15 cm2 c. Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and: i. is associated with erythema that involves at least 35 cm2 of surface area, or surface area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, cellulitis of the central face that is associated with an affected area of at least 15 cm2 5. In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of ABSSSI: a. Purulent drainage/discharge b. Fluctuance c. Heat/localized warmth d. Tenderness to palpation e. Swelling/induration

  * In patients age birth to \< 3 months, each patient must meet the following inclusion criteria to be enrolled in this study.

    1. Male or female patients from birth to \< 3 months of age, including pre-term neonates (gestational age ≥ 32 weeks)
    2. A clinical picture compatible with an ABSSSI suspected or confirmed to be caused by Gram-positive bacteria, including MRSA.

       OR

       Suspected or confirmed sepsis including any of the following clinical criteria:
       1. Hypothermia (\<36°C) OR fever (\>38.5°C)
       2. Bradycardia OR tachycardia OR rhythm instability
       3. Hypotension OR mottled skin OR impaired peripheral perfusion
       4. Petechial rash
       5. New onset or worsening of apnea episodes OR tachypnea episodes OR increased oxygen requirements OR requirement for ventilation support
       6. Feeding intolerance OR poor sucking OR abdominal distension
       7. Irritability
       8. Lethargy
       9. Hypotonia
    3. In addition, patients must meet at least one of the following laboratory criteria:

       a. White blood cell count ≤4.0 × 10\^9/L OR ≥20.0 × 10\^9/L b, Immature to total neutrophil ratio \>0.2 c. Platelet count ≤100 × 10\^9/L d. C-reactive protein (CRP) \>15 mg/L OR procalcitonin ≥ 2 ng/mL e. Hyperglycemia OR Hypoglycemia f. Metabolic acidosis
    4. Infections must be of sufficient severity to merit hospitalization and parenteral antibiotic therapy. These infections may include:

       1. Cutaneous or subcutaneous abscess
       2. Surgical site or traumatic wound infection
       3. Cellulitis, Erysipelas
       4. Omphalitis
       5. Impetigo and bullous impetigo
       6. Pustular folliculitis
       7. Scarlet fever
       8. Staphylococcal scalded skin syndrome
       9. Streptococcal toxic shock syndrome
       10. Erythematous based-erosion
       11. Other infections originating in the skin or subcutaneous tissue and associated with signs and symptoms of sepsis as defined in Inclusion Criterion 2.
    5. Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study.

Exclusion Criteria:

1. Patients age 3 months to 17 years: Clinically significant renal impairment, defined as calculated creatinine clearance of less than 30 mL/min. (calculated by the Schwartz "bedside" formula). Patients birth to \< 3 months of age: Moderate or severe renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal (× ULN) for age OR urine output \< 0.5 mL/kg/h (measured over at least 8 hours prior to dosing) OR requirement for dialysis.
2. Clinically significant hepatic impairment, defined as serum bilirubin or alkaline phosphatase greater than 2 times the upper limits of normal (ULN) for age, and/or serum aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal (ULN) for age.
3. Treatment with an investigational drug within 30 days preceding the first dose of study medication.
4. Patients with sustained shock defined as systolic blood pressure \< 90 mm Hg in children ≥ 10 years old, \< 70 mm Hg + \[2 x age in years\] in children 1 to \<10 years, or \< 70 mmHg in infants 3 to \<12 months old for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
5. More than 24 hours of any systemic antibacterial therapy within 96 hours before randomization. EXCEPTION: Microbiological or clinical treatment failure with a systemic antibiotic other than IV study drug that was administered for at least 48 hours. Failure must be confirmed by either a microbiological laboratory report or documented worsening clinical signs or symptoms.
6. Infection due to an organism known prior to study entry to be resistant to dalbavancin (dalbavancin minimum inhibitory concentration (MIC) greater than 0.25 ug/mL) or vancomycin (vancomycin minimum inhibitory concentration (MIC) greater than 2 ug/mL).
7. Patients with necrotizing fasciitis, or deep-seated infections that would require \> 2 weeks of antibiotics (e.g., endocarditis, osteomyelitis or septic arthritis).
8. Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
9. Venous catheter entry site infection.
10. Infections involving diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
11. Patient with an infected device, even if the device is removed. Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, implantable pacemaker or defibrillator, intraaortic balloon pump, left ventricular assist device, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter.
12. Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the patient should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia.
13. Patients whose skin infection is the result of having sustained full or partial thickness burns.
14. Patients age 3 months to 17 years, with uncomplicated skin infections such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure. Patients birth to \< 3 months of age may be enrolled if they have uncomplicated skin infections of sufficient severity to require hospitalization and parenteral antibiotic therapy.
15. Patients age 3 months to 17 years: Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
16. Sickle cell anemia
17. Cystic fibrosis
18. Anticipated need of antibiotic therapy for longer than 14 days.
19. Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI.
20. More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the skin infection, or patients who are expected to require more than 2 such interventions.
21. Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
22. Immunosuppression/immune deficiency, including hematologic malignancy, recent bone marrow transplant (in post-transplant hospital stay), absolute neutrophil count \< 500 cells/mm3, receiving immunosuppressant drugs after organ transplantation, receiving oral steroids ≥ 20 mg prednisolone per day (or equivalent) for \> 14 days prior to enrollment, and known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count\< 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count.
23. Known or suspected hypersensitivity to glycopeptide antibiotics, betalactam agents, aztreonam, or cephalosporins.
24. Patients with a rapidly fatal illness, who are not expected to survive for 3 months.
25. Positive urine (or serum) pregnancy test at screening (post-menarchal females only) or after admission (prior to dosing).
26. Pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use adequate contraceptive precautions. Female patients to have pregnancy testing are those who are at least 10 years old with menarche and/or thelarche (beginning of breast development).

Primary outcomes:
measure: Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit
timeFrame: Baseline, Day 28 (± 2 days)
measure: Shift From Baseline in Auditory Brainstem Response Test at TOC Visit
timeFrame: Baseline, Day 28 (± 2 days)
measure: Shift From Baseline in Acoustic Immittance Test at TOC Visit
timeFrame: Baseline, Day 28 (± 2 days)
measure: Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit
timeFrame: Baseline, Day 28 (± 2 days)
measure: Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
timeFrame: Baseline, Day 28 (± 2 days)
Secondary outcomes:
measure: Clinical Response at 48-72 Hours
timeFrame: Baseline, 48-72 hours
measure: Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
timeFrame: Baseline, Day 14 (± 2 Days)
measure: Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
timeFrame: Baseline, Day 14 (± 2 Days)
measure: Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
timeFrame: Baseline, Day 28 (± 2 Days)
measure: Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
timeFrame: Baseline, Day 28 (± 2 Days)
measure: Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome)
timeFrame: Baseline, Day 54 (± 7 days)
measure: Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor)
timeFrame: Baseline, Day 54 (± 7 days)
measure: Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
timeFrame: Baseline, 48-72 hours
measure: Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
timeFrame: Baseline, Day 14 (± 2 Days)
measure: Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
timeFrame: Baseline, Day 14 (± 2 Days)
measure: Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
timeFrame: Baseline, Day 28 (± 2 Days)
measure: Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
timeFrame: Baseline, Day 28 (± 2 Days)
measure: Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
timeFrame: Baseline, Day 54 (± 7 days)
measure: Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
timeFrame: Baseline, Day 54 (± 7 days)
measure: Microbiological Response at 48-72 Hours
timeFrame: Baseline, 48-72 hours
measure: Microbiological Response at the End of Treatment (EOT) Visit
timeFrame: Baseline, Day 14 (± 2 Days)
measure: Microbiological Response at the Test of Cure (TOC) Visit
timeFrame: Baseline, Day 28 (± 2 Days)
measure: Microbiological Response at the Follow-Up Visit
timeFrame: Baseline, Day 54 (± 7 days)
measure: Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
timeFrame: Baseline, 48-72 hours
measure: Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
timeFrame: Baseline, Day 14 (± 2 Days)
measure: Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
timeFrame: Baseline, Day 28 (± 2 Days)
measure: Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
timeFrame: Baseline, Day 54 (± 7 days)
measure: All-cause Mortality at the Test of Cure (TOC) Visit Among Cohort 5 Participants
timeFrame: Day 28 (± 2 Days)
measure: Concentration of Dalbavancin in Plasma
timeFrame: 30 min (end of infusion on Day 1); 2 hrs after start of IV (Day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of IV
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama /ID# 237446
state: Alabama
city: Phoenix
country: United States
facility: Valleywise Health Medical Center /ID# 234343
state: Arizona
city: La Palma
country: United States
facility: Southbay Pharma Research /ID# 235700
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 237533
state: California
city: Aurora
country: United States
facility: Duplicate_Children's Hospital Colorado /ID# 237622
state: Colorado
city: Panama City
country: United States
facility: Global Research Holdings LLC /ID# 235747
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital /ID# 237061
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Ferry Rd /ID# 237003
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland Medical Center /ID# 234353
state: Maryland
city: Kansas City
country: United States
facility: Duplicate_Children's Mercy Hospital and Clinics /ID# 237800
state: Missouri
city: New Brunswick
country: United States
facility: Robert Wood Johnson Univ Hosp /ID# 237862
state: New Jersey
city: New York
country: United States
facility: NYU School of Medicine /ID# 236783
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University /ID# 236831
state: New York
city: Durham
country: United States
facility: Duke University Medical Center /ID# 234315
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 237564
state: Ohio
city: Santa Fe
country: Argentina
facility: Hospital de Ninos Dr. Orlando Alassia /ID# 235562
city: Grodno
country: Belarus
facility: Grodno Regional Infectious Disease Hospital /ID# 235661
city: Mogilev
country: Belarus
facility: Mogilev Regional Children's Hospital /ID# 235657
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Center for Children /ID# 235659
city: Curitiba
country: Brazil
facility: Duplicate_Hospital Pequeno Princípe /ID# 235629
state: Parana
city: Porto Alegre
country: Brazil
facility: Duplicate_Irmandade Santa Casa de Misericórdia de Porto Alegre /ID# 235627
state: Rio Grande Do Sul
city: Bulgas
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Deva Maria EOOD Burgas /ID# 235965
city: Kozloduy
country: Bulgaria
facility: MHAT (Multiprofile Hospital for Active Treatment) /ID# 235539
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski EAD /ID# 237829
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski EAD /ID# 237830
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment ( UMHAT) Sveti Georgi EAD Plovdiv /ID# 235487
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi /ID# 237026
city: Ruse
country: Bulgaria
facility: UMHAT Kanev /ID# 237809
city: Sevlievo
country: Bulgaria
facility: Medical center 1 Sevlievo /ID# 237470
city: Sofia
country: Bulgaria
facility: MHATEM N.I.Pirogov Septic Surgery Clinic /ID# 235541
city: Sofia
country: Bulgaria
facility: SHAT Hematologic Diseases /ID# 237915
city: Stara Zagora
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Prof. Dr. Stoyan Kirkovich /ID# 235543
city: Independencia
country: Chile
facility: Hospital de Ninos Dr. Roberto del Rio /ID# 235568
city: Santiago
country: Chile
facility: Hospital El Carmen de Maipú /ID# 235570
city: Bogota
country: Colombia
facility: Fundacion Cardioinfantil /Id# 238041
state: Cundinamarca
city: Chia
country: Colombia
facility: Unidad De Investigacion Clinica Universidad De La Sabana /ID# 235566
state: Cundinamarca
city: Medellin
country: Colombia
facility: Hospital Universitario San Vic /ID# 238117
city: Batumi
country: Georgia
facility: LTD Unimedi Kakheti Batumi Maternal and Child Healthcare Center /ID# 235643
city: Tbilisi
country: Georgia
facility: LEPL Tbilisi State Medical University Givi Zhvania Academic Clinic of Pediatry /ID# 235645
city: Tbilisi
country: Georgia
facility: LTD M. Iashvili Children's Central Hospital /ID# 235639
city: Tbilisi
country: Georgia
facility: LTD Unimedi Kakheti Children New Hospital /ID# 235634
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 237398
state: Attiki
city: Stavroupoli (Thessalonikis)
country: Greece
facility: Papageorgiou General Hospital Thessaloniki /ID# 237505
state: Thessaloniki
city: Athens
country: Greece
facility: Childrens Hospital of Penteli /ID# 235667
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Hippokrateio /ID# 237186
city: Guatemala
country: Guatemala
facility: Hospital Valle del Sol /ID# 235569
city: Guatemala
country: Guatemala
facility: Hospital Roosevelt /ID# 235520
city: Guatemala
country: Guatemala
facility: Hospital del Centro Medico Infectology Department /ID# 235522
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital /ID# 237022
city: Liepaja
country: Latvia
facility: Liepaja Regional Hospital /ID# 235650
city: Riga
country: Latvia
facility: University Childrens Hospital /ID# 235648
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 236947
city: Klaipeda
country: Lithuania
facility: Klaipeda Children's Hospital /ID# 235652
city: Vilnius
country: Lithuania
facility: Duplicate_Children's Hospital Affiliate - Vilnius University Hospital Santariski /ID# 235654
city: Coyoacan
country: Mexico
facility: Instituto Nacional de Pediatria /ID# 235506
state: Ciudad De Mexico
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 237597
state: Nuevo Leon
city: Merida
country: Mexico
facility: Hospital General Dr. Agustin O'Horan /ID# 235510
state: Yucatan
city: Mexico City
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez /ID# 235508
city: Chiriquí
country: Panama
facility: Hospital Materno Infantil José Domingo de Obaldía /ID# 235625
state: Chiriqui
city: Panama City
country: Panama
facility: Hospital Del Niño Dr. José Renán Esquivel /ID# 235572
city: Bydgoszcz
country: Poland
facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 236920
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 237112
state: Mazowieckie
city: Poznan
country: Poland
facility: Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno /ID# 235518
city: Sector 2
country: Romania
facility: Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 235606
state: Bucuresti
city: Timisoara
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 235608
state: Timis
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Boli infectioase si Tropicale Dr. Victor Babes /ID# 235610
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judeatean Mures /ID# 234728
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University /ID# 236996
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical University /ID# 236239
city: Vologda
country: Russian Federation
facility: Regional Childrens Hospital /ID# 235560
city: Kempton Park
country: South Africa
facility: Peermed Clinical Trial Centre /ID# 235514
state: Gauteng
city: Middelburg
country: South Africa
facility: Mzansi Ethical Research Center /ID# 236480
state: Mpumalanga
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago /ID# 235512
state: A Coruna
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu /ID# 236797
state: Barcelona
city: Donostia
country: Spain
facility: Hospital Donostia /ID# 237773
state: Guipuzcoa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 236955
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 237775
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 237086
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Pediatric Regional Clinical Hospital /ID# 235556
state: Ivano-Frankivska Oblast
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk Regional children's Clinical Hospital /ID# 235558
city: Kropyvnytskyi
country: Ukraine
facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 237514
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital /ID# 236921
city: Poltava
country: Ukraine
facility: Ukrainian Medical Stomatological Academy - Children's City Clinical Hospital /ID# 234886
city: Uzhhorod
country: Ukraine
facility: Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 238058
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: