Efficacy and Safety of IPTp-DP Versus IPTp-SP in Malawi

• Status: Completed
• Trial end date: 2018-10-24
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims to compare the efficacy of monthly IPTp-DP with monthly IPTp-SP to determine if IPTp-DP is associated with a reduction in malaria infection at delivery among HIV-negative women in an area with high levels of SP resistance in Malawi.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Malawi College of Medicine
• Collaborator: Centers for Disease Control and Prevention
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Fanasil, pyrimethamine drug combination; Piperaquine; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Viable singleton pregnancy

• Gestational age ≤28 completed weeks (28 6/7) by fundal height/ultrasound

• Maternal age ≥16 years

• No history of IPTp use during this pregnancy

• Willing to participate and complete the study schedule, including laboratory studies and delivery in the labor ward of the study clinic or hospital

• Willing to sign or thumb print informed consent

• Resident of study area and intending to stay in the area for the duration of the follow-up

• HIV-negative at enrolment

Exclusion Criteria:

• HIV-positive or unknown

• Multiple gestation

• High-risk pregnancy, including any pre-existing illness likely to cause complication of pregnancy (hypertension, diabetes, asthma, epilepsy, renal disease, liver disease, fistula repair, leg or spine deformity)

• Severe anemia requiring blood transfusion (Hb <7.0 g/dL) at enrolment

• Known allergy or previous adverse reaction to any of the study drugs

• Previous inclusion in the same study

• Participating in other malaria intervention studies

• Known or suspected cardiac disease

• Corrected QT interval (QTcF) greater than 450 ms at baseline

• Patients taking any of the following drugs:

• Antimicrobial agents of the following classes (systemic use only):

• Macrolides (e.g. erythromycin, clarithromycin, azithromycin, roxithromycin)

• Fluoroquinolones (e.g., levofloxacin, moxifloxacin, sparfloxacin)

• Pentamidine

• Antiarrhythmic agents (e.g. amiodarone, sotalol)

• Antihistamines (e.g. promethazine)

• Antifungals (systemic): ketoconazole, fluconazole, itraconazole

• Antiretrovirals: Saquinavir

• Diuretics (e.g. hydrochlorothiazide, furosemide)

• Antipsychotics (neuroleptics): haloperidol, thioridazine

• Antidepressants: imipramine, citalopram, escitalopram

• Antiemetics: domperidone, chlorpromazine, ondansetron