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Research

Safety and efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children: randomised clinical trial

BMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7549.1055 (Published 04 May 2006) Cite this as: BMJ 2006;332:1055
  1. Hubert Barennes, epidemiologist (hubert.barennes{at}auf.org)1,
  2. Tatiana Balima-Koussoubé, general practitioner1,
  3. Nicolas Nagot, epidemiologist1,
  4. Jean-Christophe Charpentier, statistician2,
  5. Eric Pussard, pharmacologist3
  1. 1 Centre MURAZ, 01BP390 Bobo-Dioulasso, Burkina Faso
  2. 2 Methodology and Research Centre, Cernay les Reims
  3. 3 Hôpital du Kremlin Bicêtre, Service de Pharmacologie, France
  1. Correspondence to: H Barennes, Institut de la francophonie pour la médicine tropicale, BP 9519 Vientiane, Lao People's Democratic Republic
  • Accepted 23 February 2006

Abstract

Objective To compare the safety and efficacy of quinine given by the rectal route with quinine given by the intramuscular route in children with moderately severe Plasmodium falciparum malaria.

Design Randomised, open, clinical trial.

Setting Health centre in Burkina Faso.

Participants 898 children with moderately severe P falciparum malaria who were unable to take oral treatment.

Intervention Rectal quinine (20 mg/kg diluted to 30 mg/ml in water solution) or intramuscular quinine (12.5 mg/kg) every 12 hours until oral quinine could be taken.

Main outcome measures Primary safety outcome was the presence of blood in stools and secondary safety outcome was diarrhoea. Primary efficacy outcome was early treatment failure and secondary efficacy outcomes were late clinical and parasitological failures, fever clearance time, and time to oral intake.

Results Blood in stools and diarrhoea were more common in children given quinine by the rectal route than by the intramuscular route (blood in stools: 5% v 1%, absolute difference 3.9%, 95% confidence interval 1.8% to 6.1%; diarrhoea: 5% v 1%, 3.5%, 1.3% to 5.7%). On anoscopy, inflammatory lesions (9/248, 3%) were associated with bloody striations in stools. Side effects of rectal quinine were rare and transitory. Local pain (90%), inflammation (79%), and transient impairment of mobility (15%) were observed with intramuscular quinine. Early treatment failure was higher in the rectal group (6% v 3%, absolute difference 3.0%, 95% confidence interval 0.2% to 5.9%). All except two children in each group had negative blood slide results at day 5. Fever recurrence at day 7 was higher in the intramuscular group (37/375 v 18/395, absolute difference 5.3%, 1.6% to 8.9%). Other efficacy outcomes (late clinical failure, late parasitological failure, fever clearance time, time to starting oral intake and rate of deterioration to severe malaria) did not differ.

Conclusion Quinine given by the rectal route has an acceptable safety profile and could be used in the early management of moderately severe malaria in children in sub-Saharan Africa, halting progression to severe disease.

Footnotes

  • We thank the staff of Hamdallaye Health Centre, the Centre Muraz Epidemiological Unit, and the Malaria Unit (RT Guiguemde), the National Hospital Sanou Souro Medecine, Surgery and Pediatric (B Nacro) ward in Burkina Faso, the Bicêtre Hospital Pharmacological Unit (France), and the statistical staff of MRC (France); RT Guiguemde and M Sawadogo for helpful advice; A Sawadogo and F Rasoananadrasana for examination for parasites; J Achan, P Newton, L Srour, and M Strobel for revising the document. We also thank the French Ministry of Foreign Affairs for technical assistance.

  • Contributors HB was responsible for the overall coordination of the study and contributed to the study design, enrolment, examination of the children, field supervision and data analysis; He will act as guarantor for the paper. TBK enrolled and followed the children, collected and analysed the data. NN contributed to the design of the study and the interpretation of the data. JCC contributed to the analysis of the data. EP contributed to the analysis and interpretation of the data. All authors contributed to the writing of the paper.

  • Funding Impact Malaria, Sanofi-Synthelabo (Gentilly France).

  • Competing interests None declared.

  • Ethical approval Centre Muraz ethical committee and Ministry of Health of Burkina Faso. bmj.com 2006;332:1055

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