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Background  Given increasing rates of resistance to existing therapy, new options for treatment and prophylaxis of malaria are needed.    Methods  Two randomised, comparative, non-inferiority studies were conducted in Africa, one double-blinded and one open-label. Adults with fever, a positive peripheral blood smear, and a positive rapid diagnostic test for  Plasmodium falciparum  were randomised in both studies to either azithromycin (AZ) 1,000 mg plus chloroquine (CQ) 600-mg base (AZCQ 1,000 mg) once daily for three days or mefloquine hydrochloride (MQ) 1,250 mg (split dose). In the first study, an additional regimen of AZ 500 mg plus CQ 600-mg base (AZCQ 500 mg) once daily for three days was included. All study participants were hospitalised until three consecutive daily blood smears were negative for asexual  P. falciparum  parasitaemia. Study participants were evaluated weekly for 42 days, with Day 28 polymerase chain reaction (PCR)-corrected parasitological clearance rate as primary endpoint.    Results  A total of 467 subjects were randomised in the two studies. At 28 days’ follow-up, PCR-corrected parasitological clearance rates in the per protocol population in the first study were 101/103 (98%) with AZCQ 1,000 mg compared with 102/103 (99%) with MQ (95% confidence interval [CI]: -5.2, 3.3). The AZCQ 500-mg regimen was stopped during an interim study review (six [86%] clearance of seven evaluable; two lost to follow-up). In the second study, clearance rates were similar: AZCQ 1,000 mg 107/107 (100%)  vs  MQ 111/112 (99%; 95% CI: -1.8, 3.6). Among the participating countries,  in vitro  CQ resistance based on  pfcrt  mutation frequency in the baseline isolates across both studies ranged from 20.8% (Zambia) to 96.1% (Uganda). Serious adverse events (AEs; all causality) were observed more frequently with MQ compared with AZCQ (four  vs  one, respectively), though discontinuations for AEs were similar (four  vs  three, respectively). Common AEs in the AZ-containing arms included pruritus, vomiting, dizziness, and headache.    Conclusions  Among adults with symptomatic uncomplicated falciparum malaria in Africa, the combination of AZ 1,000 mg and CQ 600-mg base once daily for three days resulted in Day 28 PCR-corrected parasitological clearance rates of ≥98% and was non-inferior to treatment with MQ. AZCQ was well tolerated.    Trial registration  ClinicalTrials.gov identifiers  NCT00082576  and  NCT00367653Electronic supplementary material  The online version of this article (doi:10.1186/1475-2875-13-458) contains supplementary material, which is available to authorized users.

malaria journal

Efficacy and safety of a combination of azithromycin and chloroquine for the treatment of uncomplicated Plasmodium falciparum malaria in two multi-country randomised clinical trials in African adults