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

September 6, 2005
August 22, 2007
December 2004
Not Provided
Time to clearance (in hours) of parasitemia from blood is recorded [ Time Frame: 5 days ]
Time to clearance (in hours) of parasitemia from blood is recorded
Complete list of historical versions of study NCT00149383 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 1) Time to resolution of fever (in hours)
  • 2) AST/ALT levels (U/L)
  • 3) Capillary blood glucose (mmol/L)
  • 4) Need for ICU admission
  • 5) Tolerability of study drug/placebo as assessed by patient log
Not Provided
Not Provided
 
Safety and Efficacy Study of Adjunctive Rosiglitazone in the Treatment of Uncomplicated Falciparum Malaria
A Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone as Adjunctive Therapy for P.Falciparum Infection

The purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive rosiglitazone in the treatment of uncomplicated P.falciparum malaria.

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Falciparum Malaria
Drug: Rosiglitazone
Placebo Comparator: 2
Intervention: Drug: Rosiglitazone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
January 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00149383
033-2004
Not Provided
Not Provided
Mahidol University
McLaughlin-Rotman Center for Global Health, University of Toronto
Principal Investigator: Kevin C Kain, MD, FRCPC Faculty of Medicine, University of Toronto; McLaughlin-Rotman Center for Global Health, Toronto
Mahidol University
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP