Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT06723392
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT06723392
Study Brief:
Protocol Section:
NCT06723392