Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146718
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-05
Brief Title:
Anti-Malarial Drug Resistance in Cameroon
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Anti-malarial Drug Resistance in Cameroon Therapeutic Efficacy and Biological Markers of Resistance
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The project is a three-armed study designed to evaluate the efficacy of amodiaquineAQ sulphadoxine-pyrimethamineSP andAQSP in three sites in Cameroon that differ in their baseline characteristics for malaria In addition drug resistance will be determined by measurement of blood drug levelsand identification of molecular markers of resistance
Detailed Description:
The objectives of this study are-
to evaluate the therapeutic efficacy of amodiaquineAQ FansidarSP and the combination amodiaquineFansidar in three sites in Cameroon namely Garoua Sahel-savanna Yaounde Forest-savannah mosaic and Limbe Littoral-forest
to determine the prevalence of molecular markers associated with resistance to chloroquineAQand SP in Limbe and Garoua and of mefloquine in Yaounde
to investigate biological factors that may enhance anti-malaria therapeutic efficacy This will involve an exploratory pilot study conducted during the second year of the program
Patients will be rapidly screened for temperature and sent to the laboratory to determine the presence or absence of malaria parasites The patients will then be examined clinically for inclusion or exclusion Consent will be sort from the parents and the children randomised and assigned study numbers To avoid bias in assigning the patients to groups and to ensure equal numbers in the treatment groups blocked randomization will be performed using a table of random variables of varying block sizes The physician is blinded to what treatment the patient gets
Amodiaquine will be administered at 10mgkg on each of the three days to children in the AQ treatment group together with Fansidar dummy tablets Fansidar will be given at 25 mgkg on day 0 and quinine as rescue drug at 10mgkg per 8H for 6 days For the AQSP combination on D0 patients will be given both 25 mgkg SP and 10mgkg AQ On subsequent days the AQ or its dummy tabletsSP arm will be given
Clinical assessment during the study will include physical examination and monitoring of vital signs on D0 D3 D7 D14 and D28 Hematological measurements will include blood films haemoglobinglucoseblood drug levelsand baseline haematology A maximum of 3ml of blood will be withdrawn from the patients in Yaoundé for complete analysessee below For patients recruited at Limbe and Garoua only finger prick blood filter paper samples will be obtained
Day 0 blood samples 3mL will be collected aseptically by venepuncture before therapy from each of 50 patients in Yaoundé using acid-citrate-dextrose buffer ACD as anticoagulant This will be processed to provide plasma for immunological determinations and for haematology and blood drug level determinations
The molecular characterization of diversity and mutations
the genetic heterogeneity of the study population will be established using primers for msp1 and msp2 shown previously to distinguish between strains
PCR products will be digested with restriction enzyme RFLP-PCR for pyrimethamine resistance genes dhfr and dhps and for chloroquine resistant strains of the pfcrtgene
to evaluate the therapeutic efficacy of amodiaquineAQ FansidarSP and the combination amodiaquineFansidar in three sites in Cameroon namely Garoua Sahel-savanna Yaounde Forest-savannah mosaic and Limbe Littoral-forest
to determine the prevalence of molecular markers associated with resistance to chloroquineAQand SP in Limbe and Garoua and of mefloquine in Yaounde
to investigate biological factors that may enhance anti-malaria therapeutic efficacy This will involve an exploratory pilot study conducted during the second year of the program
Patients will be rapidly screened for temperature and sent to the laboratory to determine the presence or absence of malaria parasites The patients will then be examined clinically for inclusion or exclusion Consent will be sort from the parents and the children randomised and assigned study numbers To avoid bias in assigning the patients to groups and to ensure equal numbers in the treatment groups blocked randomization will be performed using a table of random variables of varying block sizes The physician is blinded to what treatment the patient gets
Amodiaquine will be administered at 10mgkg on each of the three days to children in the AQ treatment group together with Fansidar dummy tablets Fansidar will be given at 25 mgkg on day 0 and quinine as rescue drug at 10mgkg per 8H for 6 days For the AQSP combination on D0 patients will be given both 25 mgkg SP and 10mgkg AQ On subsequent days the AQ or its dummy tabletsSP arm will be given
Clinical assessment during the study will include physical examination and monitoring of vital signs on D0 D3 D7 D14 and D28 Hematological measurements will include blood films haemoglobinglucoseblood drug levelsand baseline haematology A maximum of 3ml of blood will be withdrawn from the patients in Yaoundé for complete analysessee below For patients recruited at Limbe and Garoua only finger prick blood filter paper samples will be obtained
Day 0 blood samples 3mL will be collected aseptically by venepuncture before therapy from each of 50 patients in Yaoundé using acid-citrate-dextrose buffer ACD as anticoagulant This will be processed to provide plasma for immunological determinations and for haematology and blood drug level determinations
The molecular characterization of diversity and mutations
the genetic heterogeneity of the study population will be established using primers for msp1 and msp2 shown previously to distinguish between strains
PCR products will be digested with restriction enzyme RFLP-PCR for pyrimethamine resistance genes dhfr and dhps and for chloroquine resistant strains of the pfcrtgene
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None