Clinical trial NCT01069900: Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection
Official title: A Randomized, Double-blind, Multicenter Trial to Evaluate the Safety and Efficacy of Sequential (Intravenous, Oral) Moxifloxacin Versus Comparator in Pediatric Subjects With Complicated Intra-abdominal Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intraabdominal Infections
Keywords: Intra-abdominal infection
Pediatric infection
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 458
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin in a pediatric population 3 months to \<18 years old. Approximately 450 pediatric subjects with a complicated intra-abdominal infection will be enrolled in the study and treated with either moxifloxacin intravenously and orally if switched to oral therapy or ertapenem (intravenously) and, if switched to oral therapy, amoxicillin/clavulanate.


Eligibility criteria: Inclusion Criteria:

* Hospitalized males or females 3 months to 17 years of age
* Able to obtain parental or legal guardian written informed consent and assent from subjects as applicable by local laws and regulations
* Expected duration of treatment with antibiotics is a minimum of 3 days administered IV, for a total of 5 to 14 days administered IV or IV followed by PO
* If the subject is a female of child-bearing potential she must have a negative pregnancy test at the screening visit or be capable of practicing an adequate method of contraception, and agree to continue the same method for 1 month following the TOC visit. Lactating subjects are not to be included.
* Subjects may be enrolled upon a surgically (laparotomy, laparoscopy, or percutaneous drainage) confirmed cIAI revealing at least one of the following:

  * Gross peritoneal inflammation with purulent exudate within the abdominal cavity
  * Intra-abdominal abscess
  * Macroscopic intestinal perforation with diffuse peritonitis OR
* Subjects may be enrolled on the basis of a suspected cIAI, which must be supported with radiological evidence (ultrasound, abdominal plain films, computed tomography \[CT\], magnetic resonance imaging \[MRI\]) of gastrointestinal perforation or localized collections of potentially infected material and at least one of the following:

  * Symptoms referable to the abdominal cavity (eg, anorexia, nausea, vomiting or pain)
  * Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity
  * Fever
  * Leukocytosis
* The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) or percutaneous drainage.

Exclusion Criteria:

* Presumed spontaneous bacterial peritonitis
* All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an cIAI secondary to pancreatitis
* Early acute or suppurative (nonperforated) appendicitis unless there is evidence of an abscess or peritoneal fluid containing pus and micro-organisms suggestive of regional contamination
* Infections originating from the female genital tract
* Known severe immunosuppression. Subjects with known mild immunosuppression (eg, Type I or II diabetes mellitus, trauma, or absolute neutrophil count \[ANC\] between 1000 and 1500 cells/mm3) may be enrolled.
* Congenital or documented acquired QT prolongation
* Receiving concomitant treatment with QT prolonging drugs
* History of tendon disease/disorder related to quinolone treatment
* Pathogenic organisms suspected or identified (eg, Pseudomonas) which are resistant to any of the study drugs
* Abnormal musculoskeletal findings at baseline assessment; or chronic musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease)
* History of myasthenia gravis

Primary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
measure: Number of Subjects With Clinical Cardiac Adverse Events
timeFrame: Clinical cardiac event related to QT interval were recorded from treatment start until day 3 of treatment. All other clinical cardiac events were recorded from treatment start to test of cure visit, up to day 56.
measure: Number of Subjects With Musculoskeletal Adverse Events
timeFrame: All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Secondary outcomes:
measure: Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term
timeFrame: All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
measure: Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
timeFrame: Baseline (Pre-dose), Day 1, Day 3
measure: PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
timeFrame: Baseline (Pre-dose), Day 1, Day 3
measure: RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
timeFrame: Baseline (Pre-dose), Day 1, Day 3
measure: QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3
timeFrame: Baseline (Pre-dose), Day 1, Day 3
measure: QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
timeFrame: Baseline (Pre-dose), Day 1, Day 3
measure: Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
timeFrame: Baseline (Pre-dose), Day 1, Day 3
measure: Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
timeFrame: Baseline (Pre-dose), Day 1, Day 3
measure: Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3
timeFrame: Baseline (Pre-dose), Day 1, Day 3
measure: Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3
timeFrame: Baseline (Pre-dose), Day 1, Day 3
measure: Clinical Response at Test-of-Cure (TOC) Visit
timeFrame: 28 to 42 days
measure: Bacteriological Response at Test-of-Cure (TOC) Visit
timeFrame: 28 to 42 days
measure: Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)
timeFrame: 28 to 42 days
measure: Clinical Response at a 'During Therapy' Visit
timeFrame: Day 3 to Day 5
measure: Bacteriological Response at a 'During Therapy' Visit
timeFrame: Day 3 to Day 5
measure: Clinical Response at the End-of-Treatment (EOT) Visit
timeFrame: Day 5 to Day 14
measure: Bacteriological Response at the End of Treatment (EOT) Visit
timeFrame: Day 5 to Day 14
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Springfield
country: United States
state: Massachusetts
city: Tres De Febrero
country: Argentina
facility: Hospital de Agudos "Dr. Carlos Bocalandro"
state: Buenos Aires
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Santiago
country: Chile
city: Olomouc
country: Czechia
city: Prague
country: Czechia
city: Stuttgart
country: Germany
state: Baden-Württemberg
city: Regensburg
country: Germany
state: Bayern
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen
city: Athens
country: Greece
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Daugavpils
country: Latvia
city: Rezekne
country: Latvia
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: México, D.F.
country: Mexico
state: Distrito Federal
city: Ecatepec de Morelos
country: Mexico
state: Estado De Mexico
city: Guadalajara
country: Mexico
state: Jalisco
city: Cusco
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Iasi
country: Romania
city: Timisoara
country: Romania
city: Smolensk
country: Russian Federation
city: Vladikavkaz
country: Russian Federation
city: Dnipropetrovsk
country: Ukraine
city: Ivano-Frankovsk
country: Ukraine
city: Lviv
country: Ukraine
city: Simferopol
country: Ukraine
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Wirth S, Emil SGS, Engelis A, Digtyar V, Criollo M, DiCasoli C, Stass H, Willmann S, Nkulikiyinka R, Grossmann U; MOXIPEDIA Study Group. Moxifloxacin in Pediatric Patients With Complicated Intra-abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study. Pediatr Infect Dis J. 2018 Aug;37(8):e207-e213. doi: 10.1097/INF.0000000000001910.