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All Profiles
Call Senior Fellowship (SF)
Programme EDCTP1
Start Date 2012-11-01
End Date 2015-01-31
Project Code TA.2011.40200.059
Status Completed

Title

Clindamycin plus quinine for treating uncomplicated falciparum malaria: an open-label randomized trial

Objectives

To measure the clinical and parasitological efficacy of Clindamycin plus quinine and Artemether-Lumefantrine (current recommended regimen) among patients between 6-59 months of age suffering from uncomplicated P. falciparum malaria, by determining the proportion of patients with Early Treatment Failures (ETF), Late Clinical Failures (LCF), Late Parasitological Failures (LPF), or with Adequate Clinical and Parasitological Response (ACPR) during a 28 day follow-up period.

Host Organisation

Institution Country
Kenya Medical Research Institute (KEMRI) Kenya

Participants

Name Institution Country
Elizabeth Juma Kenya Medical Research Institute (KEMRI) Kenya
Bernhards Ogutu Kenya Medical Research Institute (KEMRI) Kenya
John Logedi Ministry of Health Kenya
Kevin Omondi Kenya Medical Research Institute (KEMRI) Kenya

Study Design

Phase IV open-label randomised trial

Sites

Homa Bay District Hospital, Western Kenya
Ahero District Hospital

Results & Outcomes

The unadjusted cure rate was 32.6% in the clindamycin plus quinine arm and 78.9% in the artemether-lumefantrine arm. The cure rate after genotyping was 44.4% in the clindamycin plus quinine arm and 97.1% in the artemether-lumefantrine arm . Overall, 95 (53.3%) of children in the clindamycin plus quinine group developed early treatment failure compared to 1 (0.6%) in the artemether-lumefantrine group. By 72 hours after starting treatment, 50% of the children in the clindamycin plus quinine arm had not cleared their parasitemia compared to only 0.5% in the artemether-lumefantrine group. The prevalence of gametocyte carriage was significantly lower among children treated using artemetherlumefantrine compared to those treated using clindamycin plus quinine. Project Porftolio Page 388 of 622 The mean haemoglobin increased by about 1 g/dl in both groups by day 28. The prevalence of anaemia reduced by 22% (from 69.8%) in the clindamycin plus quinine arm and by 16% (from 75.5%) in the artemetherlumefantrine arm. The incidence of adverse events was comparable between the two groups. However, there were three serious adverse events (one severe anaemia and two cases of severe malaria) in the clindamycin plus quinine group. The efficacy of clindamycin plus quinine in our study was significantly lower than artemether-lumefantrine, suggesting that the continued recommendation of quinine-based combinations as second-line antimalarial drugs should be questioned.

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