In Vivo and in Vitro Efficacy of Antimalarial Treatments in Children in Burkina Faso
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Uncomplicated P. Falciparum Malaria in Children |
Drug: Artesunate-amodiaquine Drug: Artemether-lumefantrine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- PCR unadjusted treatment failure (regardless of genotyping). [ Time Frame: 42 days ] [ Designated as safety issue: No ]
- PCR adjusted treatment failure [ Time Frame: 42 days ] [ Designated as safety issue: No ]
- PCR unadjusted treatment failure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- PCR adjusted treatment failure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Fever clearance time [ Time Frame: day 1, 2, 3 ] [ Designated as safety issue: No ]
- Asexual parasite clearance time [ Time Frame: day 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]
- Gametocytaemia (prevalence and density) [ Time Frame: Day 7, 14, 21, 28, 35 and 42 ] [ Designated as safety issue: No ]
- Safety profiles of the two treatments [ Time Frame: 42 days overall ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 440 |
| Study Start Date: | December 2008 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 6 Months to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Tinto Halidou, IRSS/Centre Muraz |
| ClinicalTrials.gov Identifier: | NCT00808951 History of Changes |
| Other Study ID Numbers: | Malactres-BF |
| Study First Received: | December 5, 2008 |
| Last Updated: | June 9, 2011 |
| Health Authority: | Burkina Faso: Ministry of Health |
Keywords provided by 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:
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Amodiaquine Antimalarials Artemether Artemisinins Artesunate Lumefantrine Artemether-lumefantrine combination Amodiaquine, artesunate drug combination |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Coccidiostats Schistosomicides Antiplatyhelmintic Agents Anthelmintics Amebicides |
ClinicalTrials.gov processed this record on May 16, 2013