Ignite Creation Date:
2024-05-05 @ 9:35 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00917202
Status:
COMPLETED
Last Update Posted:
2009-06-10
First Post:
2009-06-09
Brief Title:
Efficacy of Methylene Blue for Malaria Treatment in Adults of Burkina Faso Proof of Principle Study in Semi-Immune Adults of Burkina Faso in the Frame of the A8 Project of the SFB 544
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Efficacy of Methylene Blue for Malaria Treatment in Adults of Burkina Faso Proof of Principle Study in Semi-Immune Adults of Burkina Faso in the Frame of the A8
Status:
COMPLETED
Status Verified Date:
2009-06
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:
Design Single-centre controlled study in adults with uncomplicated falciparum malaria in the Nouna Health District north-western Burkina Faso
Phase Phase II
Objectives The primary objective of this trial is to study the efficacy of different methylene blue regimens given to adults with uncomplicated falciparum malaria in an African area of high malaria transmission intensity
Population Male adults with uncomplicated malaria from Nouna town
Sample size N 60 n20 for each group three different dosing regimens of MB
Treatment The participants in the three different MB regimens will receive orally twice daily 390 mg MB total daily dose 780mg over 75 or 3 days respectively Treatment with the five three day regimen will only start after all patients of the seven five days regimen have been followed up until day 3
Endpoints The primary endpoint is the adequate clinical and parasitological response ACPR rate on day 28 Secondary endpoints are the number of adverse events AE after drug intake until day 28 clinical and parasitological failure rates on day 14 and 28 changes in haemoglobinhaematocrit until day 28 and fever and parasite clearance time
Phase Phase II
Objectives The primary objective of this trial is to study the efficacy of different methylene blue regimens given to adults with uncomplicated falciparum malaria in an African area of high malaria transmission intensity
Population Male adults with uncomplicated malaria from Nouna town
Sample size N 60 n20 for each group three different dosing regimens of MB
Treatment The participants in the three different MB regimens will receive orally twice daily 390 mg MB total daily dose 780mg over 75 or 3 days respectively Treatment with the five three day regimen will only start after all patients of the seven five days regimen have been followed up until day 3
Endpoints The primary endpoint is the adequate clinical and parasitological response ACPR rate on day 28 Secondary endpoints are the number of adverse events AE after drug intake until day 28 clinical and parasitological failure rates on day 14 and 28 changes in haemoglobinhaematocrit until day 28 and fever and parasite clearance time
Detailed Description:
None
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