Clinical trial NCT06723392: Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
Official title: Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries: a Randomized Controlled Trial of the Global Network for Women's and Children's Health Research
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Preterm Birth
Small for Gestational Age (SGA)
Stillbirth
Bacteriuria (asymptomatic) in Pregnancy
Keywords: asymptomatic bacteriuria
small vulnerable newborn
preterm birth
small for gestational agea
still birth
SVN/SB
oral nitrofurantoin monohydrate/macrocrystals
Global Network
Bangladesh
India
Pakistan
Democratic Republic of Congo
Zambia
Guatemala
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: RTI International
name: University of Virginia
name: University of Alabama at Birmingham
name: Thomas Jefferson University
name: Columbia University
name: Boston University
name: University of Colorado, Denver
name: University of North Carolina, Chapel Hill
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Kinshasa School of Public Health
name: Institute of Nutrition of Central America and Panama
name: Lata Medical Research Foundation, Nagpur
name: Aga Khan University
name: University Teaching Hospital, Lusaka, Zambia
name: KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India
First posted: 2024-12-09
Enrollment: 1134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-arm, double-blind, placebo-controlled, 2:1 allocation, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2 \[End preventable deaths of newborns and children under 5 years of age\] by examining the potential impact of this practice to reduce the incidence of SVN/SB and the lifelong health consequences associated with SVNs. In addition, the study will further explore the role and potential benefits of antibiotic treatment of AB in the pregnant individual. In total, 1,134 eligible participants, or approximately 162 per research site, will be randomized in the trial by the research teams in each of the seven international sites that, together with their United States of America (US) partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD's) Global Network for Women's and Children's Health Research (GN).


Eligibility criteria: Inclusion Criteria:

Individuals who meet the following criteria are eligible for randomization:

* Enrolled in GN MNHR
* Established pregnancy ≥12 and ≤20 weeks GA by last menstrual period and/or clinical assessment and/or ultrasonography
* Age: 18 years (or lower limit age eligible\*) to 49 years

  \* Some sites will be able to include individuals giving birth regardless of age if they are considered an adult or an emancipated minor. However, other sites will require individuals to be at least 18 years of age. The investigators will adhere to local regulations.
* Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up
* Able to provide informed consent
* Presence of a single bacterial isolate (\>105 colony forming unit (CFU)/mL) in urine at enrollment
* Intent to remain in study area for at least 42 days PP

Exclusion Criteria:

Individuals who meet any of the following criteria are not eligible for randomization:

* Gestational age \<12 weeks or \>20 weeks
* Received treatment with any antibiotic within 14 days before screening visit
* Current symptoms of UTI
* History of allergy to nitrofurantoin
* Pregnancy loss / miscarriage prior to randomization
* Currently taking magnesium-containing antacid
* Any illness / condition (e.g., anemia, diabetes, renal disease, pulmonary disease) requiring immediate medical care per site PI assessment
* Enrollment in another trial that per the study MOP will impact this trial

Primary outcomes:
measure: Number of small vulnerable newborn (SVN) or stillbirth (SB)
timeFrame: From Pregnancy until 42 days postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Icddr,B
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa School of Public Health
state: DRC
city: Guatemala City
country: Guatemala
facility: Institue for Nutrition of Central America and Panama (INCAP)
city: Belgaum
country: India
facility: KLE Academy of Higher Education and Research
state: Karnataka
city: Nagpur
country: India
facility: Lata Medical Research Foundation
state: Maharashtra
city: Karachi
country: Pakistan
facility: Aga Khan University
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
References: