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

July 30, 2015 updated by: Tinto Halidou, Centre Muraz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

440

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
    • Houet
      • Bobo-Dioulasso, Houet, Burkina Faso, 01
        • Tinto Halidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • ASAQ, Coarsucam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PCR unadjusted treatment failure (regardless of genotyping).
Time Frame: 42 days
42 days

Secondary Outcome Measures

Outcome Measure
Time Frame
PCR adjusted treatment failure
Time Frame: 42 days
42 days
PCR unadjusted treatment failure
Time Frame: 28 days
28 days
PCR adjusted treatment failure
Time Frame: 28 days
28 days
Fever clearance time
Time Frame: day 1, 2, 3
day 1, 2, 3
Asexual parasite clearance time
Time Frame: day 7, 14, 21, 28, 35, 42
day 7, 14, 21, 28, 35, 42
Gametocytaemia (prevalence and density)
Time Frame: Day 7, 14, 21, 28, 35 and 42
Day 7, 14, 21, 28, 35 and 42
Safety profiles of the two treatments
Time Frame: 42 days overall
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
before treatment and at the day of reccurrente parasitemia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Muraz

Collaborators

Institute of Tropical Medicine, Belgium

Investigators

  • Principal Investigator: Halidou Tinto, PhD, Centre Muraz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (ESTIMATE)

December 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 3, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Malactres-BF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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