Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297882
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2006-02-28
Brief Title:
Artemisinin-Based Combination Therapy Clinical Trials in Cameroon
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Phase III Clinical Trials of Artemisinin-based Combination Therapy in Cameroon
Status:
COMPLETED
Status Verified Date:
2021-05
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:
This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria combination drugs ACTs for the treatment of children aged 6-120 months in different locations in Cameroon Randomized clinical trials will provide local data on the safety of the test drugs and on putative marker mutations of the development of resistance to ACT The study will involve three centers namely Banso Guinea-Savannah region LimbeLittoral Forest and GarouaSahel-Savannah The trial will compare the efficacy and safety of AmodiaquineAQ-ArtesunateArt with CoartemArtemether-Lumefantrine Drug efficacy will be determined using a WHO standardized 28-day protocol Safety will be monitored through clinical examination and biochemical and hematological indices Molecular markers of artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles of the PfATP6 gene in drug failure cases Recrudescences or re-infections will be assessed by analysis of the msp1 and msp2 genes The impact of these combinations on generation of gametocytes will be determined from gametocyte carriage rates measured by microscopy
Detailed Description:
Outpatients will be screened for malaria by blood film examination
Malaria-positive children will be examined by the physician for inclusion or exclusionsee below
Informed consent will be sought from the guardians of potential patients
Patients or guardians will be interviewed and a case record form completed
Patients will be randomized into one of the two arms in the ratio 41 AQArt CoArtem and issued a study card
Filter paper and 5ml venous blood samples will be collected
Patients will be hospitalised for three days to allow completion of therapy under observation
The patient will be asked to return on days 7 14 and 28 for assessment of clearance or recrudescence of parasites
Patient will be examined for parasites and evaluated for early treatment failure ETF late treatment failure LTF late parasitological failure LPF or adequate clinical and parasitological responseACPR
If a patient does not appear for follow up a community health worker will try to trace them and will collect blood onto filter paper and a microscope slide should the patient have a temperature 375C
Patients whose parents opt out of the study will be administered quinine sulphate if parasitaemic
Filter paper samples will be air dried and stored with dessicant until required
Whole blood samples collected into citrate as anticoagulant will be processed for plasma aliquoted into 300µl lots and stored at -70C
Patient information will be entered at the close of each day into laptops and collectively sent to Yaounde at the end of the first month of study and thereafter at the end of each week along with the hard copies of the case report forms
Analysis will be performed on the samples within three months of collection for molecular markers of resistance genetic structure of parasites and for blood drug levels of medications used in the trial
Malaria-positive children will be examined by the physician for inclusion or exclusionsee below
Informed consent will be sought from the guardians of potential patients
Patients or guardians will be interviewed and a case record form completed
Patients will be randomized into one of the two arms in the ratio 41 AQArt CoArtem and issued a study card
Filter paper and 5ml venous blood samples will be collected
Patients will be hospitalised for three days to allow completion of therapy under observation
The patient will be asked to return on days 7 14 and 28 for assessment of clearance or recrudescence of parasites
Patient will be examined for parasites and evaluated for early treatment failure ETF late treatment failure LTF late parasitological failure LPF or adequate clinical and parasitological responseACPR
If a patient does not appear for follow up a community health worker will try to trace them and will collect blood onto filter paper and a microscope slide should the patient have a temperature 375C
Patients whose parents opt out of the study will be administered quinine sulphate if parasitaemic
Filter paper samples will be air dried and stored with dessicant until required
Whole blood samples collected into citrate as anticoagulant will be processed for plasma aliquoted into 300µl lots and stored at -70C
Patient information will be entered at the close of each day into laptops and collectively sent to Yaounde at the end of the first month of study and thereafter at the end of each week along with the hard copies of the case report forms
Analysis will be performed on the samples within three months of collection for molecular markers of resistance genetic structure of parasites and for blood drug levels of medications used in the trial
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