Nosten 1993b.
Methods | Quasi‐randomized controlled trial Generation of allocation sequence: paired, restricted, sequential trial Allocation concealment: no method reported Blinding: none Inclusion of all randomized participants: 74.4% (for treatment failure) |
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Participants | Number: 43 randomized, 32 analysed Inclusion criteria: uncomplicated P. falciparum malaria; second or third trimester; fully informed consent Exclusion criteria: none reported Average age in years (mean (standard devation)): quinine plus spiramycin group 26 (6.2); quinine plus placebo group 28 (6.8) Parity (median): quinine plus spiramycin group 2; quinine plus placebo group 4 Early/late pregnancy in gestation weeks (median): second and third trimester Symptomatic/asymptomatic malaria: many women oligosymptomatic or asymptomatic Anaemia on admission: number not reported |
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Interventions | 1. Quinine plus spiramycin
Quinine sulfate salt: 30 mg/kg every day for 5 days
Spiramycin: 2 "Miu" 3 times a day for 5 days 2. Quinine plus placebo Quinine sulfate salt: 30 mg/kg every day for 5 days |
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Outcomes | 1. Treatment failure at day 28 2. Parasite clearance time 3. Abortion 4. Adverse events | |
Notes | Location: Shoklo camp, Thai‐Burmese border Local malaria endemicity/transmission: not reported Local antimalarial drug resistance: multiple‐drug resistance (unsupervised 7‐day quinine treatment has a failure rate of 50% in pregnant women with uncomplicated malaria) Supervision of treatment: supervised Data awaiting: authors contacted, awaiting additional trial data Additional notes: despite high resistance, quinine is the only treatment available for pregnant women in the area; quinine was given as a supervised 5‐day course as this is the average actual intake when the standard 7‐day regimen is not supervised (usual practice) |