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Lapdap vs SP vs CQ for Vivax Malaria in Pakistan and Afghanistan

NCT00158561Phase 3

Key facts

Status: Completed
Start: Feb 2004
Countries: 1
Sponsor: London School of Hygiene & Tropical Medicine
Modality: Small Molecules

Drugs: chlorproguanil + dapsone
Conditions: vivax malaria

Overview

Phase 3, randomised, open-label trial of chlorproguanil + dapsone in vivax malaria (3 arms), sponsored by London School of Hygiene & Tropical Medicine. Primary endpoint: Day 14 slide clearance rate. Started Feb 2004; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

Chlorproguanil-dapsone
Chlorproguanil-dapsone (Lapdap): target doses 2.0 and 2.5 mg/kg respectively, daily for 3 days.
Sulfadoxine-pyrimethamine
Sulfadoxine-pyrimethamine (SP): target doses 1.25 and 25.0 mg/kg respectively, once only.
Chloroquine
Chloroquine (CQ): target dose 25mg/kg, daily for 3 days.

Who it enrols

Patients aged 3 years or older with microscopy-confirmed P. vivax malaria, excluding pregnant women, those with severe anaemia (Hb < 7 g/dl), visible jaundice, or recent use of antimalarial drugs.

Endpoints

Primary

Day 14 slide clearance rate14 days

Secondary

Day 28 slide clearance rate28 days
Day 14 clinical failure rate14 days
Day 28 clinical failure rate28 days
Adverse events28 days
Haemoglobin level increased by at least 1g/dl14 days
Clearance of gametocytaemia14 days
Number of subsequent malaria episodes6 months
Change in mean haemoglobin in G6PD deficient patients28 days

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