Table 4 |
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Ongoing Studies (Information extracted from Malaria in Pregnancy (MiP)* Database [42] on 05/02/2007). |
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| Study Setting |
Design & Drug Regimen |
Outcome |
Status (start date-completion date) |
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| Safety/Efficacy prevention trial in pregnancy |
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| Ifakara, Tanzania CDC/IHRDC-IMPACT |
Randomised open label, n = 1200 (400 per arm) IPTp 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) |
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| Safety/Efficacy Treatment trial in Pregnancy |
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| 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) |
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| Efficacy/Pharmacokinetic trial in Pregnancy |
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| 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) |
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| Pharmacovigilance: Post-marketing surveillance |
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| 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) |
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* MiP is a consortium of experts in the field of malaria funded by the Bill and Melinda Gates Foundation to review current research and develop future research strategy for malaria in pregnancy. One of the key objectives of MiP is to create a database containing all published and unpublished research and a trial registry on malaria in pregnancy. Abbreviations: ACT: artemisinin combination therapy; AE: adverse events; ANC: antenatal care; BW: birthweight; CDC: Centers for Disease Control & Prevention; GMP: Gates Malaria Partenership; DRC: Democratic Republic of the Congo; IHRDC: Ifakara Health Research and Development Centre; IPTp: intermittent presumptive treatment for pregnancy; NIH-NICHD: National Institutes of Health-The National Institute of Child Health and Human Development; RCT: randomized controlled trials; SP: sulphadoxine-pyrmethamine; TBB: Thai-Burmese Border; UNC: University of North Carolina; UCT: University of Cape Town; WHO-TDR: World Health Organization – The Special Programme for Research and Training in Tropical Diseases |
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Dellicour et al. Malaria Journal 2007 6:15 doi:10.1186/1475-2875-6-15 |
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