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Trial record 1 of 1 for:    NCT00808951
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In Vivo and in Vitro Efficacy of Antimalarial Treatments in Children in Burkina Faso

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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

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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Artesunate-amodiaquine Drug: Artemether-lumefantrine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Artemether -lumefantrine
Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
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)

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
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




Primary Outcome Measures :
  1. PCR unadjusted treatment failure (regardless of genotyping). [ Time Frame: 42 days ]

Secondary Outcome Measures :
  1. PCR adjusted treatment failure [ Time Frame: 42 days ]
  2. PCR unadjusted treatment failure [ Time Frame: 28 days ]
  3. PCR adjusted treatment failure [ Time Frame: 28 days ]
  4. Fever clearance time [ Time Frame: day 1, 2, 3 ]
  5. Asexual parasite clearance time [ Time Frame: day 7, 14, 21, 28, 35, 42 ]
  6. Gametocytaemia (prevalence and density) [ Time Frame: Day 7, 14, 21, 28, 35 and 42 ]
  7. Safety profiles of the two treatments [ Time Frame: 42 days overall ]
  8. 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 ]


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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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): NCT00808951


Locations
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Burkina Faso
Tinto Halidou
Bobo-Dioulasso, Houet, Burkina Faso, 01
Sponsors and Collaborators
Centre Muraz
Institute of Tropical Medicine, Belgium
Investigators
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Principal Investigator: Halidou Tinto, PhD Centre Muraz
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tinto Halidou, PharmD, PhD, Centre Muraz
ClinicalTrials.gov Identifier: NCT00808951    
Other Study ID Numbers: Malactres-BF
First Posted: December 16, 2008    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015
Keywords provided by Tinto Halidou, Centre Muraz:
Uncomplicated malaria
P falciparum
Children
National treatment protocol
Burkina Faso
Artemether-lumefantrine
Artesunate-amodiaquine
In vivo efficacy
In vitro efficacy
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Artesunate
Lumefantrine
Artemether
Artemether, Lumefantrine Drug Combination
Amodiaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics