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| Name | Class |
|---|---|
| RTI International | OTHER |
| University of Virginia | OTHER |
| University of Alabama at Birmingham | OTHER |
| Thomas Jefferson University |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral nitrofurantoin monohydrate/macrocrystals | Drug | 7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of small vulnerable newborn (SVN) or stillbirth (SB) | SVN/SB, defined by the occurrence of any of the following:
| From Pregnancy until 42 days postpartum |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icddr,B | Recruiting | Dhaka | Bangladesh | Bangladesh |
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| OTHER |
| Columbia University | OTHER |
| Boston University | OTHER |
| University of Colorado, Denver | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| Kinshasa School of Public Health | OTHER |
| Institute of Nutrition of Central America and Panama | OTHER |
| Lata Medical Research Foundation, Nagpur | OTHER |
| Aga Khan University | OTHER |
| University Teaching Hospital, Lusaka, Zambia | OTHER |
| KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India | UNKNOWN |
Parallel-arm, double-blind, placebo-controlled, 2:1 allocation, randomized controlled trial
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| Placebo | Other | 7-day course of oral placebo 100 mg twice daily (total of 14 doses) |
|
| Kinshasa School of Public Health | Not yet recruiting | Kinshasa | DRC | Democratic Republic of the Congo |
|
| Institue for Nutrition of Central America and Panama (INCAP) | Not yet recruiting | Guatemala City | Departamento de Guatemala | Guatemala |
|
| KLE Academy of Higher Education and Research | Recruiting | Belagavi | Karnataka | India |
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| Lata Medical Research Foundation | Not yet recruiting | Nagpur | Maharashtra | India |
|
| Aga Khan University | Not yet recruiting | Karachi | Pakistan | Pakistan |
|
| University Teaching Hospital | Not yet recruiting | Lusaka | Zambia | Zambia |
|
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D050497 | Stillbirth |
| D001437 | Bacteriuria |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005313 | Fetal Death |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014552 | Urinary Tract Infections |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009582 | Nitrofurantoin |
| ID | Term |
|---|---|
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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