Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479206
Status:
COMPLETED
Last Update Posted:
2008-04-30
First Post:
2007-05-25
Brief Title:
Artemisinin Resistance in Cambodia
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Artemisinin Resistance in Cambodia
Status:
COMPLETED
Status Verified Date:
2008-04
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 principal aim of this project is to investigate reports of developing artemisinin resistance in Cambodia using an integrated in vivo - in vitro approach to examine recent alarming reports of treatment failures with advanced combination therapies along the Thai-Cambodian border which could have major impact on the malaria situation in the affected areas as well as the rest of the malaria-endemic world
Detailed Description:
A total number of 90 volunteers with acute uncomplicated falciparum malaria will be randomly assigned to be treated with either artesunate monotherapy for 7 days or the combination of quinine and tetracycline over 7 days following the 2nd line national treatment guideline of the national malaria control program at a ratio of 21 The study design will be based on the WHO recommendations for the Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria WHO 2003 Study participants will be otherwise healthy malaria patients adult men and non-pregnant women aged 18 to 65 years with uncomplicated falciparum malaria recruited in Battambong Province Cambodia
The artesunate will be administered orally a single dose of 200 mg per day over a total duration of 7 days Directly Observed Therapy Quinine 30 mgkgday plus tetracycline 25 mgkgday will also be administered over 7 days in split dose every 8 hours following the national treatment guidelines of Cambodia
Patients will be admitted to the hospital for the duration of study drug administration or until all signs and symptoms of malaria have disappeared whichever comes first Thereafter until Day 21 patients have to remain in a malaria-free environment such as Sampov Luon or Ta Sanh either in the hospital or in a living facility provided at the study site where the patients will be supervised by study personnel After Day 21 they will be followed as outpatients until Day 28 with a scheduled follow-up visit on Day 28
In vitro drug sensitivity assays will be performed from samples on inclusion and in case of recrudescence Drug levels will be measured in the artesunate arm on the first and last day of therapy
Primary clinical outcome is cure Adequate Clinical and Parasitological Response - ACPR on Day 28 Secondary outcome measures are time until parasite fever and gametocyte clearance PCT FCT and GCT Parasite genotyping will be used to distinguish recrudescences from reinfections by PCR Subjects will be monitored for clinical adverse events throughout the study duration
Blood will be drawn on the day of admission before initiating therapy for in vitro drug sensitivity testing and for PCR markers of drug resistance and to distinguish recrudescence from reinfection by genotyping Malaria smears will be prepared up to 4 times a day until parasite clearance and on Days 7 14 21 and 28 or whenever symptoms consistent with malaria appear Plasma samples for determining drug levels will be obtained on the first and last day of therapy Over the entire study up to approximately 64 ml of blood may be drawn by venipuncture Study participation for each individual will be 28 days
The artesunate will be administered orally a single dose of 200 mg per day over a total duration of 7 days Directly Observed Therapy Quinine 30 mgkgday plus tetracycline 25 mgkgday will also be administered over 7 days in split dose every 8 hours following the national treatment guidelines of Cambodia
Patients will be admitted to the hospital for the duration of study drug administration or until all signs and symptoms of malaria have disappeared whichever comes first Thereafter until Day 21 patients have to remain in a malaria-free environment such as Sampov Luon or Ta Sanh either in the hospital or in a living facility provided at the study site where the patients will be supervised by study personnel After Day 21 they will be followed as outpatients until Day 28 with a scheduled follow-up visit on Day 28
In vitro drug sensitivity assays will be performed from samples on inclusion and in case of recrudescence Drug levels will be measured in the artesunate arm on the first and last day of therapy
Primary clinical outcome is cure Adequate Clinical and Parasitological Response - ACPR on Day 28 Secondary outcome measures are time until parasite fever and gametocyte clearance PCT FCT and GCT Parasite genotyping will be used to distinguish recrudescences from reinfections by PCR Subjects will be monitored for clinical adverse events throughout the study duration
Blood will be drawn on the day of admission before initiating therapy for in vitro drug sensitivity testing and for PCR markers of drug resistance and to distinguish recrudescence from reinfection by genotyping Malaria smears will be prepared up to 4 times a day until parasite clearance and on Days 7 14 21 and 28 or whenever symptoms consistent with malaria appear Plasma samples for determining drug levels will be obtained on the first and last day of therapy Over the entire study up to approximately 64 ml of blood may be drawn by venipuncture Study participation for each individual will be 28 days
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSRRB A-13922 | None | None | None |