Antimalarial Drug Resistance in Mali
|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: NCT00127998|
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : August 16, 2006
Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic polymorphisms that give rise to resistant P. falciparum parasites and methods in population genetics for evaluating the data can be valuable tools for monitoring drug resistance in the field. This study aims to:
- Prospectively measure the in vivo response of P. falciparum malaria in Mali to several different antimalarial drugs and drug combinations: chloroquine (CQ), sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested.
- Measure the frequencies of molecular markers for antimalarial drug resistance, and examine how those results relate to the efficacy of these drugs in treating clinical malaria
- Measure drug levels at 3 days and correlate with efficacy results.
- Examine early clinical, parasitologic, and clinical predictors of late treatment failure.
- Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for antimalarial drugs.
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: chloroquine Drug: sulfadoxine-pyrimethamine Drug: amodiaquine Drug: amodiaquine+artesunate Drug: amodiaquine+sulfadoxine-pyrimethamine Drug: sulfadoxine-pyrimethamine+artesunate Drug: artemether-lumefantrine Drug: mefloquine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1011 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Characterization of Novel Molecular Tools for the Epidemiological Surveillance of Antimalarial Drug Resistance in Mali|
|Study Start Date :||July 2005|
- Early Treatment Failure (ETF, defined as: Development of danger signs or severe malaria on Day 1, 2, or 3, in the presence of parasitemia
- Parasitemia on Day 2 higher than Day 0 count irrespective of axillary temperature
- Parasitemia on Day 3 with axillary temperature ≥37.5°C
- Parasitemia on Day 3 ≥ 25% of count on Day 0
- Late Clinical Failure (LCF), defined as: Development of danger signs or severe malaria from Day 4 to Day 28 in the presence of parasitemia, without previously meeting any of the criteria of ETF
- Presence of parasitemia and axillary temperature ≥37.5° C on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF
- Late parasitological failure (LPF), defined as: Presence of parasitemia on Day 14 to Day 28 and axillary temperature <37.5°C without previously meeting any of the criteria of ETF or LCF
- Adequate Clinical and Parasitological Response (ACPR), defined as: Absence of parasitemia on Day 28 irrespective of axillary temperature, without previously meeting any of the criteria of ETF, LCF or LPF
- Frequencies of dhfr, dhps, pfcrt and pfmdr1 P. falciparum genotypes and relationship with in vivo resistance to SP (dhfr and dhps), CQ, AQ, SP/AQ, AQ/AS, SP/AS, and MQ
- Drug levels at 3 days and correlation with in vivo efficacy results
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): NCT00127998
|Faladje Missionary Dispensary|
|Koro Health Center|
|Pongono Community Health Center|
|Principal Investigator:||Robert D. Newman, MD, MPH||Centers for Disease Control and Prevention|
|Principal Investigator:||Kassoum Kayentao, MD, MSPH||Malaria Research and Training Center, Bamako, Mali|
|Principal Investigator:||John Barnwell, PhD, MPH||Centers for Disease Control and Prevention|
|Principal Investigator:||Ogobara Doumbo, MD, PhD||Malaria Research and Training Center, Bamako, Mali|