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Rosiglitazone Adjunctive Therapy for Severe Malaria in Children

NCT02694874 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-02-21

No results posted yet for this study

Summary

Even with optimal anti-malaria therapy and supportive care, severe and cerebral malaria are associated with a 10-30% mortality rate and neurocognitive deficits in up to 33% of survivors. Adjunctive therapies that modify host immune-pathological processes may further improve outcome over that possible with anti-malarials alone. Investigators aim to evaluate a PPARγ agonist ( "rosiglitazone") as adjunctive therapy for severe malaria.

Conditions

Interventions

DRUG

Rosiglitazone

This is the experimental drug, rosiglitazone, being tested against placebo to assess its efficacy as an adjunctive treatment for severe malaria

DRUG

Placebo

This is the placebo control

Sponsors & Collaborators

  • University Health Network, Toronto

    collaborator OTHER

  • Barcelona Institute for Global Health

    collaborator OTHER

  • Centro de Investigacao em Saude de Manhica

    lead OTHER

Principal Investigators

  • Eusebio Macete, PhD · Fundaçao Manhiça

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2020-03-31
Completion
2021-12-31

Countries

  • Mozambique

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02694874 on ClinicalTrials.gov