Intermittent Presumptive Treatment in Pregnancy With Sulfadoxine-Pyrimethamine using Rapid Diagnostic Test Screening And Treatment at First Antenatal Care Visit

Phase 3

• Conditions: Malaria; Neonatal Diseases; Pregnancy and Childbirth

• Registration Number: PACTR201905721140808
• Lead Sponsor: Tropical Diseases Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: Female
• Target Recruitment: 392

Inclusion Criteria

•Gestational age of 16 to 24 weeks at enrolment;
•Asymptomatic* on presentation
•Hb = 7 g/dL;
•HIV negative at enrolment
•No history of IPTp-SP or antimalarial drug use during the current pregnancy
•At least 15 years old;
•Residence within the health facility catchment’s area;
•Willing to deliver at the health facility;
•Willing to adhere to the study requirements (HIV voluntary counselling and testing (VCT included);
•Ability to provide written informed consent; if the woman is minor of age/not emancipated, the consent must be
given by a parent or legal guardian according to national law (An assent will also be obtained from the participant).
Asymptomatic defined as absence of fever (temperature <37.5 °C) at baseline; less than three of the following symptoms: fever in the past 24 h, weakness/fatigue; muscle and/or joint aches, headache

Exclusion Criteria

•HIV positive or unknown at enrolment
•Hb<7 g/dl
•History of allergic reactions to the study drugs;
•History of known pregnancy complications or bad obstetric history including pre-existing illness likely to cause complication of pregnancy such as repeated abortions, stillbirths or eclampsia;
•History or presence of major illnesses likely to influence pregnancy outcome including hypertension, diabetes
mellitus, asthma, epilepsy, renal disease, liver disease, fistula repair, heart disease, or active tuberculosis;
•Current cotrimoxazole prophylaxis or ARV treatment;
•Any significant illness at the time of screening that requires hospitalization, including severe malaria;
•Intent to move out of the study catchment area before delivery or deliver at relative’s home out of the catchment
area.
•Prior enrolment in the study or concurrent enrolment in another study.
•Unable to take oral medication
•Clear evidence of recent (2 weeks) treatment with antimicrobials with antimalarial activity (clindamycin,
azithromycin, clarithromycin, levofloxacin etc.);
•On at least one of the following drugs: Pentamidine, Antiarrhythmic agents (e.g. amiodarone, sotalol),
Antihistamines (e.g. promethazine), Antifungals (systemic): ketoconazole, fluconazole, itraconazole, Diuretics (e.g.
hydrochlorothiazide, furosemide), Antipsychotics (neuroleptics): haloperidol, thioridazine, Antidepressants:
imipramine, citalopram, escitalopram, Antiemetics: domperidone, chlorpromazine, ondansetron

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Relative hazard of P. falciparum infection diagnosed by PCR at day 42 after randomization<br>•Medication-related adverse events and serious adverse events until 1-year post-partum<br><br>