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Safety and Efficacy Study of Adjunctive Rosiglitazone in the Treatment of Uncomplicated Falciparum Malaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00149383
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : April 13, 2015
Sponsor:
Collaborator:
McLaughlin-Rotman Center for Global Health, University of Toronto
Information provided by (Responsible Party):
Mahidol University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Falciparum Malaria Drug: Rosiglitazone Drug: Placebo Phase 1 Phase 2

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 (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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of Rosiglitazone as Adjunctive Therapy for P.Falciparum Infection
Study Start Date : December 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 2 Drug: Placebo
Experimental: 1 Drug: Rosiglitazone


Outcome Measures
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Primary Outcome Measures :
  1. Time to clearance (in hours) of parasitemia from blood is recorded [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Time to resolution of fever (in hours) [ Time Frame: 5 days ]
  2. AST/ALT levels (U/L) [ Time Frame: 2 days ]
  3. Capillary blood glucose (mmol/L) [ Time Frame: 2 days ]
  4. Need for ICU admission [ Time Frame: 5 days ]
  5. Tolerability of study drug/placebo as assessed by patient log [ Time Frame: 5 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Microscopically confirmed P.falciparum infection
  • Age >18 years
  • Able to tolerate oral therapy
  • Able to give informed consent

Exclusion Criteria:

  • Fulfillment of WHO criteria for severe/cerebral malaria
  • Prior treatment with any thiazolidinedione
  • Allergy to rosiglitazone
  • History of diabetes mellitus
  • History of severe/decompensated liver disease
  • ALT level >2.5 times normal
  • Current treatment for congestive heart failure
  • Pregnancy or breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149383


Locations
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Thailand
Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
McLaughlin-Rotman Center for Global Health, University of Toronto
Investigators
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Principal Investigator: Kevin C Kain, MD, FRCPC Faculty of Medicine, University of Toronto; McLaughlin-Rotman Center for Global Health, Toronto
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT00149383    
Other Study ID Numbers: 033-2004
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015
Keywords provided by Mahidol University:
randomized controlled trial
malaria
Plasmodium falciparum
 thiazolidinediones
rosiglitazone
atovaquone-proguanil
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Infections
 Vector Borne Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs