From: The safety of artemisinins during pregnancy: a pressing question
Study Setting | Design & Drug Regimen | Outcome | Status (start date-completion date) |
---|---|---|---|
Safety/Efficacy prevention trial in pregnancy | |||
Ifakara, Tanzania CDC/IHRDC-IMPACT | Randomised open label, n = 1200 (400 per arm) IPT p Control: SP 2 doses Intervention: 1. SP monthly 2. SP+artesunate monthly | 1°: Placental parasitaemia and AEs 2°: Maternal illness and parasitaemia at delivery, birth outcome (BW, Gestational age, foetal and infant health), childhood developmental milestones | Recruitment concluded; ongoing follow up (01/03-ongoing) |
Safety/Efficacy Treatment trial in Pregnancy | |||
ANC at Muheza Hospital, Tanzania GMP | Randomised open label, target (Phase III) n = 350 2nd or 3rd trimesters Control: SP Intervention: SP+amodiaquine, Amodiaquine+artesunate, Chloroporguanil-dapsone | 1°: Treatment failure at day 28; Treatment outcome (parasite/fever clearance, parasite recrudescence) 2°: Foetal viability and birth outcomes (preterm delivery, foetal death, perinatal/neonatal mortality, neonatal abnormality); maternal AE (hypoglycaemia) | Recruitment completed (01/04–07/06) |
Shoklo Malaria Research Unit (SMRU) ANC, Thailand UNICEF-UNDP-World Bank-WHO-TDR | Randomized intervention trial n = 250 2nd or 3rd trimesters Group 1: Artesunate Group 2: Co-artemether (artemether/lumefantrine) | 1°: Treatment outcome at day 42 or at delivery (parasite/fever clearance, parasite recrudescence) 2°:Gametocyte carriage; pharmacokinetic parameters; histo-pathology examination of the placenta | Currently recruiting (06/02/2004–31/12/2008) |
Bangladesh WHO | Randomised controlled trial n = 684 Control: placebo rectal capsule Intervention: Artesunate rectal capsule | Pregnancy outcomes | Currently recruiting (10/11/2003-ongoing) |
Malawi; Prof Meshnick, UNC | Randomised open label, n = 141 2nd or 3rd trimesters Control: SP Intervention: SP+artesunate or SP+azithromycin | 1°: Parasitological failure rates; parasite clearance time; fever clearance times and incidence rate of adverse events 2°: Prevalence rate of abortions; still births; peripheral parasitaemia at delivery; placental malaria and of maternal anaemia | Recruitment completed (09/2003–10/2005) |
Efficacy/Pharmacokinetic trial in Pregnancy | |||
Mozambique UCT, South Africa | Non-Randomized openLabel, target n = 30 2nd or 3rd trimester pregnant HistoricalControl Intervention: SP+artesunate | 1°: Pharmacokinetic parameters 2°: gametocyte carriage, maternal AE & birth outcomes | Currently recruiting (03/2006–09/2008) |
Kinshasa, DRC, NIH-NICHD | Dose-equivalence trial: part of investigational new drug application n = 60 2nd or 3rd trimester Control: SP Intervention: Artesunate-mefloquine combinations | Pharmacokinetic parameters | Recruitment completed (07/2005–12/2005) |
Pharmacovigilance: Post-marketing surveillance | |||
Tanzania, CDC | Pharmacovigilance surveillance system: part of a large ongoing study to look at district wide use of ACTs 1st trimester Control: SP Intervention: SP+Artesunate | Pregnancy outcome and status of child | Ongoing (2005–2007) |
A partnership between Novartis WHO-TDR and the Government of Zambia. [43] | Pregnancy Registry Prospective active surveillance cohort. Expected n = 1600 Control: SP Intervention: artemether-lumefantrine | Maternal and neonatal outcomes examined | Ongoing (2005) |