Clinical trial
Lungwena Antenatal Intervention Study. A Single-centre Intervention Trial in Rural Malawi, Testing Maternal and Infant Health Effects of Presumptive Intermittent Treatment of Pregnant Women With Sulfadoxine-pyrimethamine and Azithromycin
Name
SA-179787-1
Description
The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and result in other health benefits both for the mother and the foetus/newborn.
Trial arms
Trial start
2003-12-01
Estimated PCD
2007-06-01
Trial end
2025-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Sulfadoxine-pyrimethamine treatment twice during pregnancy
Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks.
2 placebo tablets for azithromycin taken at the same time points.
Arms:
Control
Other names:
Control
Sulfadoxine-pyrimethamine at 4-week intervals
Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and then at 4 week intervals until 37.0 gestation weeks.
2 placebo tablets for azithromycin taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks.
Arms:
Monthly SP
Other names:
Monthly SP
Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice
Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and then at 4 week intervals until 37.0 gestation weeks.
2 azithromycin tablets (each 500 mg) taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks.
Arms:
AZI-SP
Other names:
Azi-SP
Size
1320
Primary endpoint
Proportion of preterm births
once, after delivery
Number of serious adverse events
Cumulative during pregnancy and neonatal period
Eligibility criteria
Inclusion Criteria:
* Signed informed consent
* Age \>= 15 years
* Ultrasound confirmed pregnancy
* Quickening
* Foetal age 14-26 gestation weeks
* Maternal availability for follow-up during the entire study period
Exclusion Criteria:
* Known maternal tuberculosis, diabetes, kidney disease or liver disease
* Any severe acute illness warranting hospital referral at enrollment visit
* Mental disorder that may affect comprehension of the study or success of follow-up
* Twin pregnancy
* Pregnancy complications evident at enrollment visit (moderate to severe oedema, blood hemoglobin \[Hb\] concentration \< 50 g/l, systolic blood pressure \[BP\] \> 160 mmHg or diastolic BP \> 100 mmHg)
* Prior receipt of azithromycin during this pregnancy
* Receipt of sulfadoxine and pyrimethamine within 28 days of enrollment
* Known allergy to drugs containing sulfonamides, macrolides or pyrimethamine
* History of anaphylaxis
* History of any serious allergic reaction to any substance, requiring emergency medical care
* Concurrent participation in any other clinical trial
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1320, 'type': 'ACTUAL'}}
Updated at
2023-11-29
1 organization
2 products
4 indications
Organization
Tampere UniversityProduct
Sulfadoxine-pyrimethamineIndication
MalariaIndication
Sexually Transmitted InfectionsIndication
premature birthIndication
Pregnancy