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Treatment of Malaria With Quinine Plus Sulfadoxine-Pyrimethamine

This study has been completed.
Sponsor:
Information provided by:
Albert Schweitzer Hospital
ClinicalTrials.gov Identifier:
NCT00167739
First received: September 11, 2005
Last updated: September 19, 2005
Last verified: September 2005

September 11, 2005
September 19, 2005
April 2003
Not Provided
Proportion of cured patients by day 28
Same as current
Complete list of historical versions of study NCT00167739 on ClinicalTrials.gov Archive Site
  • 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
  • -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
Not Provided
Not Provided
 
Treatment of Malaria With Quinine Plus Sulfadoxine-Pyrimethamine
Short Course of Quinine Plus a Single Dose of Sulphadoxine-Pyrimethamine for Plasmodium Falciparum Malaria

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria
Drug: Quinine plus sulfadoxine-pyrimethamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2004
Not Provided

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
Both
2 Years to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
Gabon
 
NCT00167739
04/2003/Q/SP
Not Provided
Not Provided
Albert Schweitzer Hospital
Not Provided
Principal Investigator: Michel A. Missinou, PhD Albert Schweitzer Hospital
Albert Schweitzer Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP