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

This study has been completed.
Sponsor:
Collaborator:
McLaughlin-Rotman Center for Global Health, University of Toronto
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00149383
First received: September 6, 2005
Last updated: August 22, 2007
Last verified: January 2006
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone as Adjunctive Therapy for P.Falciparum Infection

Resource links provided by NLM:


Further study details as provided by Mahidol University:

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

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

Enrollment: 140
Study Start Date: December 2004
Study Completion Date: January 2006
Arms Assigned Interventions
Placebo Comparator: 2 Drug: Rosiglitazone

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149383

Locations
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
Principal Investigator: Kevin C Kain, MD, FRCPC Faculty of Medicine, University of Toronto; McLaughlin-Rotman Center for Global Health, Toronto
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00149383     History of Changes
Other Study ID Numbers: 033-2004
Study First Received: September 6, 2005
Last Updated: August 22, 2007
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
randomized controlled trial
malaria
Plasmodium falciparum
thiazolidinediones
rosiglitazone
atovaquone-proguanil

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014