Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries

NCT06723392 | Recruiting Phase 3 DMC

• 1 other identifier: CP ABLE
• Study Type: interventional
• Target: 1,134
• Locations: 6 countries
• Sites: 7

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).

Conditions

Small for Gestational Age (SGA); Stillbirth; Preterm Birth; 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

Outcome Measures

Primary Outcomes (1)

• Number of small vulnerable newborn (SVN) or stillbirth (SB)

  SVN/SB, defined by the occurrence of any of the following: * PTB, defined by birth \<37 completed weeks gestation; * SGA, defined by birth weight \<10th percentile of weight for gestational age, using INTERGROWTH 21st international, sex-specific birthweight standards; or * SB, defined by fetal loss or SB \> 22 weeks' gestation.

  From Pregnancy until 42 days postpartum

Study Arms (2)

Oral nitrofurantoin monohydrate/macrocrystals

EXPERIMENTAL

Pregnant individuals with AB randomized to receive a 7-day course of oral NM/M 100 mg twice daily (total of 14 doses)

Drug: Oral nitrofurantoin monohydrate/macrocrystals

Placebo

PLACEBO COMPARATOR

Pregnant individuals with AB randomized to a receive a 7-day course of oral placebo 100 mg twice daily (total of 14 doses)

Other: Placebo

Interventions

Placebo OTHER

7-day course of oral placebo 100 mg twice daily (total of 14 doses)

Placebo

Oral nitrofurantoin monohydrate/macrocrystals DRUG

7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)

Oral nitrofurantoin monohydrate/macrocrystals

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead
• RTI International: collaborator
• University of Virginia: collaborator
• University of Alabama at Birmingham: collaborator
• Thomas Jefferson University: collaborator
• Columbia University: collaborator
• Boston University: collaborator
• University of Colorado, Denver: collaborator
• University of North Carolina, Chapel Hill: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Kinshasa School of Public Health: collaborator
• Institute of Nutrition of Central America and Panama: collaborator
• Lata Medical Research Foundation, Nagpur: collaborator
• Aga Khan University: collaborator
• University Teaching Hospital, Lusaka, Zambia: collaborator
• KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India: collaborator

Study Sites (7)

Icddr,B

Dhaka, Bangladesh, Bangladesh

RECRUITING

Kinshasa School of Public Health

Kinshasa, DRC, Democratic Republic of the Congo

NOT YET RECRUITING

Institue for Nutrition of Central America and Panama (INCAP)

Guatemala City, Departamento de Guatemala, Guatemala

NOT YET RECRUITING

KLE Academy of Higher Education and Research

Belagavi, Karnataka, India

RECRUITING

Lata Medical Research Foundation

Nagpur, Maharashtra, India

NOT YET RECRUITING

Aga Khan University

Karachi, Pakistan, Pakistan

NOT YET RECRUITING

University Teaching Hospital

Lusaka, Zambia, Zambia

NOT YET RECRUITING

MeSH Terms

Conditions

Premature Birth; Stillbirth; Bacteriuria

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urinary Tract Infections; Infections; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Parallel-arm, double-blind, placebo-controlled, 2:1 allocation, randomized controlled trial

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 8, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

DE (1); GU (1); BA (1); IN (2); PA (1); ZA (1)