Rosiglitazone Adjunctive Therapy for Severe Malaria in Children

• Register: ClinicalTrials.gov
• Last refreshed on: 4 March 2024
• Main ID: NCT02694874
• Date of registration: 09/12/2015
• Prospective Registration: Yes
• Primary sponsor: Centro de Investigacao em Saude de Manhica
• Public title: Rosiglitazone Adjunctive Therapy for Severe Malaria in Children ROSI
• Scientific title: Rosiglitazone Adjunctive Therapy for Severe Malaria in Children
• Date of first enrolment: February 2016
• Target sample size: 210
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02694874
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Mozambique

Contacts

• Name: Eusebio Macete, PhD
• Affiliation: Fundaçao Manhiça

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 1-12 years

- Positive 3-band (HRPII plus pLDH) P. falciparum rapid diagnostic test (RDT) and
microscopy confirmed malaria infection with parasitemia >2500 parasites/microlitre if
microscopy is available in a timely manner at the time of randomization.

- One or more features of severe malaria: repeated seizures (two or more generalized
seizures in 24 h); prostration (in children 1 year and older, the child is unable to
sit unsupported or stand although was able to before the illness); impaired
consciousness (Blantyre Coma Score <5 in children 1 to 4 years, GCS <14 for children =
5 years); respiratory distress: age related tachypnea with sustained nasal flaring,
deep breathing or subcostal retractions

- Requiring hospitalization and parenteral artesunate for their malaria infection based
on admitting physician assessment

Exclusion Criteria:

- P. falciparum RDT negative OR infection not confirmed by light microscopy or not
reaching the predefined inclusion criterion parasitemia threshold according to age

- Uncomplicated malaria infection not requiring hospitalization

- Presenting with severe malaria anemia (SMA) alone (Hb < 50g/L)

- Known underlying illness: neurological or neurodegenerative disorders, cardiac, renal,
or hepatic disease, diabetes, epilepsy, cerebral palsy, children known to be HIV-1
positive and receiving antiretroviral treatment*

- Previous treatment with a TZD

- Unable to remain in research site region for the follow up period



Age minimum: 12 Months
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: Placebo

Drug: Rosiglitazone

Primary Outcome(s)

Change in serum Ang-2 levels in the first 96 hours of hospital admission. [Time Frame: first 96 hours of hospital admission.]

Secondary Outcome(s)

Mortality [Time Frame: first 48h post-hospital admission and at 14 days post-hospital admission]

AE/SAE [Time Frame: up to day 14 after hospital admission]

Blood glucose levels [Time Frame: up to 96 hours after hospital admission]

Change in levels of biomarkers of host response [Time Frame: at admission, every 12h for 24 hours then daily for 4 days, and once on day 14 and 6 month follow ups]

Blood lactate levels, assessed at admission, every 12h for 24 hours then daily for Blood lactate levels [Time Frame: Assessed at admission, every 12h for 24 hours then daily for 4 days, and once on day 14 and 6 month follow ups]

Cardiac effects [Time Frame: from baseline to 24h, and day 4]

Time to parasitological recovery [Time Frame: up to 96 hours after hospital admission]

Neurocognitive outcomes [Time Frame: From baseline to 6 months post discharge, and 18 months post discharge]

Biochemical and hematological parameters [Time Frame: up to 96 hours after hospital admission]

Time to clinical recovery [Time Frame: up to 96 hours after hospital admission]

Secondary ID(s)

ROSI_v03_22072015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Health Network, Toronto

Barcelona Institute for Global Health