Treatment of Malaria With Quinine Plus Sulfadoxine-Pyrimethamine
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| ClinicalTrials.gov Identifier: NCT00167739 |
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Recruitment Status :
Completed
First Posted : September 14, 2005
Last Update Posted : September 21, 2005
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Malaria | Drug: Quinine plus sulfadoxine-pyrimethamine | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 50 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Short Course of Quinine Plus a Single Dose of Sulphadoxine-Pyrimethamine for Plasmodium Falciparum Malaria |
| Study Start Date : | April 2003 |
| Study Completion Date : | February 2004 |
- Proportion of cured patients by day 28
- Proportion of gametocytes carriers during the hospitalisation period and on days 7, 14, 21, and 28
- Parasite clearance time
- Fever clearance time
- Assessment of adverse events during the study period
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| Ages Eligible for Study: | 2 Years to 7 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Uncomplicated falciparum malaria
- Asexual parasitaemia between 20,000 and 200,000/µL
- No mixed plasmodial infection
- Fever with temperature above 38 °C or history of fever during the preceding 24 hours
- No effective anti-malarial treatment for the present attack
- Informed consent
Exclusion Criteria:
- Haemoglobin < 7 g/dL
- Packed-cell volume < 20%
- White cell count > 16,000/µL
- Platelet count < 40,000/µL
- Schizontaemia > 50/µL
- Impaired consciousness
- Convulsions or history of convulsions
- Concomitant diseases masking assessment of response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167739
| Gabon | |
| Medical Research Unit, Lambaréné | |
| Lambaréné, Moyen Ogooué, Gabon, B.P. 118 | |
| Principal Investigator: | Michel A. Missinou, PhD | Albert Schweitzer Hospital |
Publications:
| ClinicalTrials.gov Identifier: | NCT00167739 |
| Other Study ID Numbers: |
04/2003/Q/SP |
| First Posted: | September 14, 2005 Key Record Dates |
| Last Update Posted: | September 21, 2005 |
| Last Verified: | September 2005 |
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Malaria Quinine Sulfadoxine-pyrimethamine Gabon |
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Malaria Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases Pyrimethamine Sulfadoxine Fanasil, pyrimethamine drug combination Quinine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Muscle Relaxants, Central Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents |