Assessing the benefits of using effective malaria diagnostic tests in preventing complications associated with malaria in pregnancy in a high-risk malaria area of Nchelenge in Zambia

Phase 3

• Conditions: Malaria diagnostic and prevention in pregnant women; Infections and Infestations

• Registration Number: ISRCTN45944555
• Lead Sponsor: Tropical Diseases Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-11
• Last Update Posted: 29 April 2024
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 254

Inclusion Criteria

1. Gestational age of 16 to 26 weeks at enrolment
2. Asymptomatic* on presentation
3. Hb = 7 g/dL
4. HIV negative at enrolment
5. No history of IPTp-SP or antimalarial drug use during the current pregnancy
6. At least 15 years old
7. Residence within the health facility catchment area
8. Willing to deliver at the health facility
9. Willing to adhere to the study requirements (HIV voluntary counseling and testing (VCT included)
10. Ability to provide written informed consent; if the woman is a minor of age/not emancipated, the consent must be given by a parent or legal guardian according to national law

(* Asymptomatic defined as the 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. An assent will also be obtained from the participant).

Exclusion Criteria

1. HIV positive or unknown at enrolment
2. Hb<7 g/dl
3. History of allergic reactions to the study drugs
4. 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
5. 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
6. Current cotrimoxazole prophylaxis or ARV treatment
7. Any significant illness at the time of screening that requires hospitalization, including severe malaria
8. Intent to move out of the study catchment area before delivery or deliver at relative’s home out of the catchment area
9. Prior enrolment in the study or concurrent enrolment in another study
10. Unable to take oral medication
11. Clear evidence of recent (2 weeks) treatment with antimicrobials with antimalarial activity (clindamycin, azithromycin, clarithromycin, levofloxacin etc.)
12. 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