Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

In Vivo and in Vitro Efficacy of Antimalarial Treatments in Children in Burkina Faso

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00808951
Recruitment Status : Completed
First Posted : December 16, 2008
Last Update Posted : August 3, 2015
Sponsor:
Collaborator:
Institute of Tropical Medicine, Belgium
Information provided by (Responsible Party):
Tinto Halidou, Centre Muraz

Tracking Information
First Submitted Date  ICMJE December 5, 2008
First Posted Date  ICMJE December 16, 2008
Last Update Posted Date August 3, 2015
Study Start Date  ICMJE December 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
PCR unadjusted treatment failure (regardless of genotyping). [ Time Frame: 42 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
  • PCR adjusted treatment failure [ Time Frame: 42 days ]
  • PCR unadjusted treatment failure [ Time Frame: 28 days ]
  • PCR adjusted treatment failure [ Time Frame: 28 days ]
  • Fever clearance time [ Time Frame: day 1, 2, 3 ]
  • Asexual parasite clearance time [ Time Frame: day 7, 14, 21, 28, 35, 42 ]
  • Gametocytaemia (prevalence and density) [ Time Frame: Day 7, 14, 21, 28, 35 and 42 ]
  • Safety profiles of the two treatments [ Time Frame: 42 days overall ]
  • Parasites in vitro sensitivity to the drugs tested and their relationship with the in vivo results [ Time Frame: before treatment and at the day of reccurrente parasitemia ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE In Vivo and in Vitro Efficacy of Antimalarial Treatments in Children in Burkina Faso
Official Title  ICMJE In Vivo and in Vitro Efficacy of the Recommended First Line Antimalarial Treatments (Artemether-Lumefantrine and Amodiaquine-Artesunate) in Children With Uncomplicated Malaria in Burkina Faso
Brief Summary Resistance to antimalarial drugs represents a major obstacle for controlling malaria in endemic countries, so that most sub-Saharan countries have changed their antimalarial drug policy to the new Artemisinin Containing Therapies. Burkina Faso has changed its policy for uncomplicated malaria to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS), but there are still little available data on safety and efficacy of these treatments in Burkina Faso; both treatments have shown to be efficacious, but AL seems to have higher occurrence of recurrent malaria infections during a 28-day follow up period. Thus, this study aims at comparing the safety and efficacy of AL and AS-AQ (42-day follow-up), AND also at comparing their in vitro sensitivity, in patients with recurrent infection, with the results obtained in vivo.
Detailed Description Plasmodium falciparum resistance to antimalarial drugs represents the major drawback and obstacle for controlling malaria in endemic countries; that's why most sub-Saharan countries have changed their antimalarial drug policy to Artemisinin Containing Therapies (ACT), which produce a rapid clinical and parasitological cure, reduce gametocyte carriage rate and are generally well tolerated. Burkina Faso has recently changed its policy for the treatment of uncomplicated malaria, from Chloroquine to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, there are still little available data on safety and efficacy of these treatments in Burkina Faso; a recent study carried out in Bobo Dioulasso showed that both treatments were extremely efficacious (adjusted treatment failure less than 5%) but with AL showing significantly high occurrence of recurrent infections during the 28-day follow up period. The higher risk for recurrent infections for AL was confirmed in a subsequent trial comparing AL with AQ-SP and dihydroartemisinin-piperaquine, but so far no direct comparison between AQ+AS and AL has been completed, though a study in Nanoro, near Ouagadougou, is ongoing. Thus, the present study aims at comparing the in vivo safety and efficacy of AL and AS-AQ (42-day follow-up),AND at comparing the in vitro sensitivity of the different ACT components, in patients with recurrent infection, with the results obtained in vivo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malaria
Intervention  ICMJE
  • Drug: Artesunate-amodiaquine
    Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)
    Other Name: ASAQ, Coarsucam
  • Drug: Artemether-lumefantrine
    Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing > 35 kg.
    Other Name: AL, Coartem(R), Riamet(R)
Study Arms  ICMJE
  • Experimental: Artemether -lumefantrine
    Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
    Intervention: Drug: Artemether-lumefantrine
  • Experimental: Artesunate-amodiaquine
    Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso
    Intervention: Drug: Artesunate-amodiaquine
Publications * Lingani M, Bonkian LN, Yerbanga I, Kazienga A, Valéa I, Sorgho H, Ouédraogo JB, Mens PF, Schallig HDFH, Ravinetto R, d'Alessandro U, Tinto H. In vivo/ex vivo efficacy of artemether-lumefantrine and artesunate-amodiaquine as first-line treatment for uncomplicated falciparum malaria in children: an open label randomized controlled trial in Burkina Faso. Malar J. 2020 Jan 6;19(1):8. doi: 10.1186/s12936-019-3089-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2008)
440
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 6 - 59 months
  • Weight > 5 kg
  • Mono-infection with P. falciparum
  • Parasitemia of 4,000-200,000 asexual parasites per µl
  • Fever: > 37.5 °C or history of fever in the preceding 24 hours
  • Haemoglobin > 5.0 g/dl
  • Signed informed consent by the parents or guardians
  • Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial.

Exclusion Criteria:

  • Participation in any other clinical trial during the previous 30 days
  • Known hypersensitivity to the study drugs
  • Severe and/or complicated malaria (cases will be referred to Bobo-Dioulasso University hospital for treatment)
  • Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;
  • Known intercurrent illness or any condition which would place the subject at undue risk or interfere with the results of the study.
  • Severe malnutrition (weight for height <70% of the median NCHS/WHO reference)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Burkina Faso
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00808951
Other Study ID Numbers  ICMJE Malactres-BF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tinto Halidou, Centre Muraz
Study Sponsor  ICMJE Centre Muraz
Collaborators  ICMJE Institute of Tropical Medicine, Belgium
Investigators  ICMJE
Principal Investigator: Halidou Tinto, PhD Centre Muraz
PRS Account Centre Muraz
Verification Date July 2015

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