Treatment of Malaria With Quinine Plus Sulfadoxine-Pyrimethamine
NCT ID: NCT00167739
Last Updated: 2005-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2003-04-30
2004-02-29
Brief Summary
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The efficacy of a 3-day treatment of quinine plus sulfadoxine-pyrimethamine for the treatment of hospitalised, uncomplicated malaria cases was assessed.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Quinine plus sulfadoxine-pyrimethamine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
7 Years
ALL
No
Sponsors
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Albert Schweitzer Hospital
OTHER
Principal Investigators
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Michel A. Missinou, PhD
Role: PRINCIPAL_INVESTIGATOR
Albert Schweitzer Hospital
Locations
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Medical Research Unit, Lambaréné
Lambaréné, Moyen-Ogooué Province, Gabon
Countries
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References
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Kremsner PG, Winkler S, Brandts C, Neifer S, Bienzle U, Graninger W. Clindamycin in combination with chloroquine or quinine is an effective therapy for uncomplicated Plasmodium falciparum malaria in children from Gabon. J Infect Dis. 1994 Feb;169(2):467-70. doi: 10.1093/infdis/169.2.467.
Alloueche A, Bailey W, Barton S, Bwika J, Chimpeni P, Falade CO, Fehintola FA, Horton J, Jaffar S, Kanyok T, Kremsner PG, Kublin JG, Lang T, Missinou MA, Mkandala C, Oduola AM, Premji Z, Robertson L, Sowunmi A, Ward SA, Winstanley PA. Comparison of chlorproguanil-dapsone with sulfadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in young African children: double-blind randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1843-8. doi: 10.1016/S0140-6736(04)16350-2.
Bousema JT, Gouagna LC, Meutstege AM, Okech BE, Akim NI, Githure JI, Beier JC, Sauerwein RW. Treatment failure of pyrimethamine-sulphadoxine and induction of Plasmodium falciparum gametocytaemia in children in western Kenya. Trop Med Int Health. 2003 May;8(5):427-30. doi: 10.1046/j.1365-3156.2003.01047.x.
Kremsner PG, Krishna S. Antimalarial combinations. Lancet. 2004 Jul 17-23;364(9430):285-94. doi: 10.1016/S0140-6736(04)16680-4.
Athan E, Durrheim DN, Barnes K, Mngomezulu NM, Mabuza A, Govere J. Effectiveness of short-course quinine and single-dose sulfadoxine-pyrimethamine in the treatment of Plasmodium falciparum malaria in Mpumalanga Province, South Africa. S Afr Med J. 2001 Jul;91(7):592-4.
Rahman MR, Paul DC, Rashid M, Ghosh A, Bangali AM, Jalil MA, Faiz MA. A randomized controlled trial on the efficacy of alternative treatment regimens for uncomplicated falciparum malaria in a multidrug-resistant falciparum area of Bangladesh--narrowing the options for the National Malaria Control Programme? Trans R Soc Trop Med Hyg. 2001 Nov-Dec;95(6):661-7. doi: 10.1016/s0035-9203(01)90108-7.
Ogutu BR, Nzila AM, Ochong E, Mithwani S, Wamola B, Olola CH, Lowe B, Kokwaro GO, Marsh K, Newton CR. The role of sequential administration of sulphadoxine/pyrimethamine following quinine in the treatment of severe falciparum malaria in children. Trop Med Int Health. 2005 May;10(5):484-8. doi: 10.1111/j.1365-3156.2005.01415.x.
Deloron P, Mayombo J, Le Cardinal A, Mezui-Me-Ndong J, Bruzi-Baert C, Lekoulou F, Elissa N. Sulfadoxine-pyrimethamine for the treatment of Plasmodium falciparum malaria in Gabonese children. Trans R Soc Trop Med Hyg. 2000 Mar-Apr;94(2):188-90. doi: 10.1016/s0035-9203(00)90272-4.
Hall AP, Doberstyn EB, Mettaprakong V, Sonkom P. Falciparum malaria cured by quinine followed by sulfadoxine-pyrimethamine. Br Med J. 1975 Apr 5;2(5961):15-7. doi: 10.1136/bmj.2.5961.15.
Hall AP, Doberstyn EB, Karnchanachetanee C, Samransamruajkit S, Laixuthai B, Pearlman EJ, Lampe RM, Miller CF, Phintuyothin P. Sequential treatment with quinine and mefloquine or quinine and pyrimethamine-sulfadoxine for falciparum malaria. Br Med J. 1977 Jun 25;1(6077):1626-8. doi: 10.1136/bmj.1.6077.1626.
de Souza JM, Sheth UK, de Oliveira RM, Roulet H, de Souza SD. An open, randomized, phase III clinical trial of mefloquine and of quinine plus sulfadoxine-pyrimethamine in the treatment of symptomatic falciparum malaria in Brazil. Bull World Health Organ. 1985;63(3):603-9.
Related Links
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General information on malaria at the website of the Malaria Foundation International
Homepage of the Medical Research unit, Lambarene
Other Identifiers
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04/2003/Q/SP
Identifier Type: -
Identifier Source: org_study_id