Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486694
Status:
COMPLETED
Last Update Posted:
2007-06-15
First Post:
2007-06-13
Brief Title:
Artesunate Plus Sulfadoxine-Pyrimethamine Versus Chloroquine for Vivax Malaria
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
A Randomised Non-Inferiority Trial of Sulfadoxine-Pyrimethamine Plus Artesunate Compared to Chloroquine for the Treatment of Vivax Malaria in Eastern Afghanistan
Status:
COMPLETED
Status Verified Date:
2007-06
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:
The purpose of this study was to determine whether the proposed first line treatment for falciparum malaria in this region sulfadoxine-pyrimethamine artesunate would be no worse a treatment for vivax malaria that the standard vivax treatment of chloroquine In areas where vivax and falciparum malaria co-exist misdiagnosis of vivax malaria as falciparum is not unlikely it is important to know whether adequate treatment will be received in these cases
Detailed Description:
In areas co-endemic for falciparum and vivax malaria incorrect differential diagnosis is always a risk Where the recommended treatment for the two diseases is the same this presents no problem for effective treatment or clinical cure of either species Chloroquine remains an effective treatment of choice for vivax malaria in most settings but with the spread of chloroquine-resistant falciparum malaria across Asia many countries now use artemisinin-based combination therapy for this species of malaria Differential diagnostic practices have not improved in parallel In Afghanistan the adoption of sulfadoxine-pyrimethamine plus artesunate SPAS as first-line falciparum treatment raises the prospect of a significant proportion of vivax malaria being misdiagnosed and treated with the combination SP is considered to have limited efficacy against vivax malaria and the efficacy of SPAS against vivax has not been established in areas that have made the switch A randomized non-inferiority trial comparing SPAS 1 day SP 3 days AS to chloroquine monotherapy was undertaken on 190 vivax patients in Eastern Afghanistan A margin of equivalence of 14 with 90 power and 95 CI two-sided α 005 was used Standard WHO procedures for in vivo evaluation of antimalarial drugs were followed 180 individuals completed the trial to day 42 The primary outcome was proportion of patients free from failure at day 28 Using a per protocol analysis both regimens resulted in 96 treatment success at 28 days but significantly more cases failed in the CQ arm 46 than in the SPAS arm 24 by day 42 Based on predetermined statistical criteria SPAS was shown to be non-inferior to the standard chloroquine treatment In areas where vivax infections might be misdiagnosed as falciparum infections and treated with SPAS patient management would be as good or better than with the standard CQ treatment
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