Malaria Neonatal Diseases Pregnancy and Childbirth
Conditions
Interventions
IPTpSP
IPTpSP Plus
Sponsors
Tropical Diseases Research Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Relative hazard of P. falciparum infection diagnosed by PCR at day 42 after randomization •Medication-related adverse events and serious adverse events until 1-year post-partum | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion with treatment or prevention failure at day 42 stratified according to study drug (SP or DP); • Relative hazard of P. falciparum infection diagnosed by PCR or microscopy at days 14, 28, 35, 42, 63, delivery, and 1-month post-partum in infants; • Proportion who experience at least one episode of P. falciparum infection by day 14, 28, 35, 42, or 63; • Median time to first episode of malaria in pregnancy; • Acute, chronic, and prior placental infection at delivery; • Mean birth weight and prevalence of low birth weight (within 72 hours post-partum); • Neonatal mortality (within 28 days post-partum); • Congenital malaria diagnosed by PCR, placental malaria diagnosed by histopathology using placental biopsies; • Maternal anemia (hemoglobin changes at days 14, 28, 42 and 63); • Congenital anemia; • Incidences of pregnancy losses; • Congenital P. falciparum infection; • Relative allele frequencies of genotypic markers of drug resistance in malaria parasites; • Terminal elimination half-life of piperaquine determined by noncompartmental analysis of drug concentrations at 0, 14, 28, 35 and 42 days; | — |
Countries
Zambia
Contacts
Public ContactSebastian Hachizovu
Tropical Diseases Research Centre
Outcome results
None listed