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Sponsors and Collaborators: |
Albert Schweitzer Hospital, Netherlands Medical Research Unit, Lambaréné |
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Information provided by: | Albert Schweitzer Hospital, Netherlands |
ClinicalTrials.gov Identifier: | NCT00167739 |
Quinine remains the treatment of choice of hospitalised malaria cases. The long treatment duration of 7 days, and adverse reactions often hamper its adequate use. Reducing the treatment duration by adding sulfadoxine-pyrimethamine may enhance compliance and reduce side effects.
The efficacy of a 3-day treatment of quinine plus sulfadoxine-pyrimethamine for the treatment of hospitalised, uncomplicated malaria cases was assessed.
Condition | Intervention | Phase |
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Malaria |
Drug: Quinine plus sulfadoxine-pyrimethamine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Short Course of Quinine Plus a Single Dose of Sulphadoxine-Pyrimethamine for Plasmodium Falciparum Malaria |
Estimated Enrollment: | 50 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | February 2004 |
One main concern of clinicians in malaria endemic areas is to find a simple malaria treatment with short treatment duration. The concept of combination therapy, which may reduce treatment duration and delay the spread of drug resistance in addition to an increase in efficacy, has been therefore introduced.
In contrast to the outpatient treatment of malaria where emergence of resistance has lead to new drugs policies, the treatment of hospitalised malaria cases remains, in many endemic countries, intravenous quinine for 7 days. The efficacy of this regimen is well established throughout Africa. The effectiveness of the quinine treatment may be considerably lower because of discontinuation of treatment due to early discharge, the occurrence of side effects or because of the fact that patients feel better and stop the treatment. Therefore, sulfadoxine-pyrimethamine (SP) is often added at discharge. This regimen has been shown to be effective. But in Africa, where the practice seems widespread, it has been assessed in only two trials.
Since resistance of Plasmodium falciparum to SP is increasing rapidly in Africa and there is evidence that SP monotherapy induce gametocytaemia, we hypothesize that the combination quinine/SP increases SP efficacy and prevents induction of gametocytaemia. In addition, since the use of the full course of quinine therapy may be hampered by many factors (hospital cost, hospitalisation duration, availability of beds, compliance and side effects), the addition of the long acting SP to complete a short course of quinine treatment may prevent recrudescence or reinfection and may increase effectiveness of malaria treatment and reduce postdischarge morbidity.
The efficacy and safety of the short course of intravenous quinine (3-day treatment) plus a single dose of oral SP for the treatment of falciparum malaria was investigated.
Ages Eligible for Study: | 2 Years to 7 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Gabon, Moyen Ogooué | |
Medical Research Unit, Lambaréné | |
Lambaréné, Moyen Ogooué, Gabon, B.P. 118 |
Principal Investigator: | Michel A. Missinou, PhD | Medical Research Unit, Lambaréné |
Study ID Numbers: | 04/2003/Q/SP |
Study First Received: | September 11, 2005 |
Last Updated: | September 19, 2005 |
ClinicalTrials.gov Identifier: | NCT00167739 |
Health Authority: | Gabon: Ministry of Research |
Malaria Quinine Sulfadoxine-pyrimethamine Gabon |
Folic Acid Pyrimethamine Protozoan Infections Sulfadoxine-pyrimethamine Quinine |
Parasitic Diseases Malaria Sulfadoxine Malaria, Falciparum |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Physiological Effects of Drugs Anti-Infective Agents, Urinary Enzyme Inhibitors Neuromuscular Agents Renal Agents Folic Acid Antagonists |
Pharmacologic Actions Antimalarials Antiparasitic Agents Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Muscle Relaxants, Central Analgesics Peripheral Nervous System Agents Central Nervous System Agents |