Rectal artemether versus intravenous quinine for the treatment of cerebral malaria in children in Uganda: randomised clinical trial

Aceng, Jane Ruth; Byarugaba, Justus; Tumwine, James

doi:10.1136/bmj.330.7487.334

Cited by 53 publications

(34 citation statements)

References 15 publications

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“…The longer parasite clearance times in the study in Niger [15] may also have occurred because of the longer intervals in assessing serial parasite densities. Our study also revealed an evidently shorter trend in time to parasite clearance than did an earlier study in Uganda by Aceng et al [14] that used rectal artemether (43.1 h vs. 54.2 h;…”

Section: Discussioncontrasting

confidence: 54%

“…The explanation for this may be the systematic use of paracetamol and tepid sponging for temperature control in our study. Our study also had shorter fever clearance times, compared with some studies using rectal artemether [14,20]. The explanation for this may be the more erratic absorption of artemether suppositories [21].…”

Section: Discussionmentioning

confidence: 78%

“…We calculated a sample size of 54 patients in each group, for 90% power and 95% CIs. We assumed that the children receiving intravenous quinine would have a mean parasite clearance (‫ע‬SD) of h (27.5% effect size), according to a 55.0 ‫ע‬ 24.3 study by Aceng et al [14] in the same hospital, and that those receiving intrarectal quinine would have a mean parasite clearance time (‫ע‬SD) of h; using these clearance times, 39.9 ‫ע‬ 24.3 we were able to identify a difference that was approximately twice that observed by Barennes et al [15] (6.8 h) between intrarectal quinine and intravenous quinine in Niger. Efficacy was powered as being superior for intrarectal quinine, because the local standard of care does not recommend a loading dose of intravenous quinine [13].…”

Section: Participantsmentioning

confidence: 99%

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Rectal versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria in Kampala, Uganda: A Randomized, Double-Blind Clinical Trial

Achan¹,

Byarugaba²,

Hubert³

et al. 2007

Clinical Infectious Diseases

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Background. Although artemesinin derivatives are promising for the treatment of severe Plasmodium falciparum malaria, intravenous quinine remains the most affordable treatment. However, administration of intravenous quinine is often not feasible in rural areas in Africa because of the lack of simple equipment or trained staff. We compared the efficacy and safety of intrarectal quinine with those of intravenous quinine in the treatment of childhood cerebral malaria.Methods. In a randomized, double-blind clinical trial at Mulago Hospital (Kampala, Uganda), Uganda's national referral hospital, we studied 110 children aged 6 months to 5 years who had cerebral malaria. Patients were randomized to receive either intrarectal or intravenous quinine. Main outcome measures included parasite clearance time, fever clearance time, coma recovery time, time to sit unsupported, time to begin oral intake, time until oral quinine was tolerated, and death.Results. Overall, there was no difference in the clinical and parasitological outcomes between the 2 groups (data are deviation, intrarectal quinine group vs. intravenous quinine group): coma recovery time, h versus mean ‫ע‬ standard 19.4 ‫ע‬ 18.1 h; fever clearance time, h versus h; and parasite clearance time, h versus 17.0 ‫ע‬ 12.1 26.7 ‫ע‬ 16.1 29.9 ‫ע‬ 18.1 43.2 ‫ע‬ 14.2 h. Mortality was similar in both groups; 4 of 56 patients in the intrarectal quinine group died, and 5 of 54 patients 41.9 ‫ע‬ 15.2 in the intravenous quinine group died (odds ratio, 1.3; 95% confidence interval, 0.3-5.2). Intrarectal quinine was well tolerated, and no major immediate adverse events occurred.Conclusions. Intrarectal quinine is efficacious and could be used as an alternative in the treatment of childhood cerebral malaria, especially in situations in which intravenous therapy is not feasible.

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Section: Discussioncontrasting

confidence: 54%

Section: Discussionmentioning

confidence: 78%

Section: Participantsmentioning

confidence: 99%

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Rectal versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria in Kampala, Uganda: A Randomized, Double-Blind Clinical Trial

Achan¹,

Byarugaba²,

Hubert³

et al. 2007

Clinical Infectious Diseases

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“…Rectal artesunate is unlikely to challenge either parenteral artesunate or quinine in hospital practice, but it may have a significant role in pre-hospital settings, especially in rural parts of Africa where the bulk of malaria deaths occur. A trial in Uganda comparing rectal artemether with intravenous quinine showed a trend towards lower mortality, faster parasite clearance and faster time to defervescence in the artemether arm compared with the quinine arm; however, these results failed to reach statistical significance [36] and rectal artesunate may well fare better [37]. A recent multicenter trial of rectal artesunate used in a rural setting has recently been completed and will report shortly.…”

Section: Drug Safetymentioning

confidence: 92%

Artesunate, artemether or quinine in severePlasmodium falciparummalaria?

Whitty¹

2007

Expert Review of Anti-infective Therapy

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Quinine and the artemisinin-derivative drugs artesunate and artemether are effective treatments for severe falciparum malaria. Trials comparing artemether with quinine have not demonstrated convincing evidence of a mortality advantage for artemether. The South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT), a multicenter, randomized, open-label trial in 1461 adults with severe malaria in Asia compared artesunate with quinine. Mortality was 15% in the artesunate group and 22% in the quinine group, a reduction of 34.7% (95% confidence interval: 18.5-47.6%) in the artesunate group, with almost all the benefit reported in those with high parasite counts. Artesunate should constitute first-line treatment for severe malaria in Asia. These results can probably be generalized to the treatment of severe malaria in adults from all areas, especially in those with hyperparasitemia. However, it is unclear whether these results can be generalized to children in Africa, who constitute the majority of those who die from severe malaria worldwide.

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“…In this issue Aceng et al report a randomised trial of intravenous quinine compared with rectal artemether in cerebral malaria 3. They found that the effects of intravenous quinine and rectal artemether were comparable, both in terms of efficacy and time to recover.…”

mentioning

confidence: 99%