|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Mahidol University |
|---|---|
| Collaborator: |
McLaughlin-Rotman Center for Global Health, University of Toronto |
| Information provided by: | Mahidol University |
| ClinicalTrials.gov Identifier: | NCT00149383 |
Purpose
The purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive rosiglitazone in the treatment of uncomplicated P.falciparum malaria.
| Condition | Intervention | Phase |
|---|---|---|
|
Falciparum Malaria |
Drug: Rosiglitazone |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone as Adjunctive Therapy for P.Falciparum Infection |
| Enrollment: | 140 |
| Study Start Date: | December 2004 |
| Study Completion Date: | January 2006 |
| Arms | Assigned Interventions |
|---|---|
| 2: Placebo Comparator | Drug: Rosiglitazone |
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 (atovaquone/proguanil) 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Thailand | |
| Faculty of Tropical Medicine, Mahidol University | |
| Bangkok, Thailand, 10400 | |
| Principal Investigator: | Kevin C Kain, MD, FRCPC | Faculty of Medicine, University of Toronto; McLaughlin-Rotman Center for Global Health, Toronto |
More Information
| Study ID Numbers: | 033-2004 |
| Study First Received: | September 6, 2005 |
| Last Updated: | August 22, 2007 |
| ClinicalTrials.gov Identifier: | NCT00149383 History of Changes |
| Health Authority: | Thailand: Ethical Committee |
|
randomized controlled trial malaria Plasmodium falciparum |
thiazolidinediones rosiglitazone atovaquone-proguanil |
|
Protozoan Infections Hypoglycemic Agents Coccidiosis Physiological Effects of Drugs Parasitic Diseases |
Malaria Rosiglitazone Pharmacologic Actions Malaria, Falciparum |