Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149383
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2005-09-06
Brief Title:
Safety and Efficacy Study of Adjunctive Rosiglitazone in the Treatment of Uncomplicated Falciparum Malaria
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Trial of Rosiglitazone as Adjunctive Therapy for PFalciparum Infection
Status:
COMPLETED
Status Verified Date:
2015-04
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 purpose of this study is to examine the safety tolerability and efficacy of adjunctive rosiglitazone in the treatment of uncomplicated Pfalciparum malaria
Detailed Description:
Study Rationale Evidence suggests that if PPAR-RXR agonists such as rosiglitazone are used as adjunctive therapy in P falciparum malaria infections they may increase phagocytic clearance of P falciparum malaria modulate deleterious inflammatory responses and decrease sequestration of malaria parasites in vital organs They may therefore represent a novel immunomodulatory treatment approach for P falciparum malaria
Study Objectives 1 To examine the in vivo effect of rosiglitazone on the rapidity of clearance of P falciparum parasitemia and fever in patients with non-severe P falciparum infections 2 To assess the safety and tolerability of adjunctive rosiglitazone treatment in non-severe cases of P falciparum infection
Primary Outcomes Time to clearance of P falciparum parasitemia
Study Design Randomized double blind placebo-controlled trial
Intervention Standard antimalarial treatment atovaquoneproguanil to all patients combined with adjuvant rosiglitazone treatment 8mg per day or placebo
Setting Hospital for Tropical Diseases at Mahidol University Thailand
Participants 140 patients with non-severe P falciparum infection
Follow-up 28 days
Study Objectives 1 To examine the in vivo effect of rosiglitazone on the rapidity of clearance of P falciparum parasitemia and fever in patients with non-severe P falciparum infections 2 To assess the safety and tolerability of adjunctive rosiglitazone treatment in non-severe cases of P falciparum infection
Primary Outcomes Time to clearance of P falciparum parasitemia
Study Design Randomized double blind placebo-controlled trial
Intervention Standard antimalarial treatment atovaquoneproguanil to all patients combined with adjuvant rosiglitazone treatment 8mg per day or placebo
Setting Hospital for Tropical Diseases at Mahidol University Thailand
Participants 140 patients with non-severe P falciparum infection
Follow-up 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