MedTrace Logo

Dexamethasone for Cerebral Toxoplasmosis

NCT04341155 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-07-03

No results posted yet for this study

Summary

Toxoplasma gondii infects over one third of the global human population. Cerebral toxoplasmosis is the most common opportunistic infection in HIV patients resulting in up to 50% of mortality with proper treatment and 80% without it. The fatality mainly due to the brain edema resulted from the mass effect lesion. In addition of anti toxoplasmosis given, adjunctive therapy such as steroid is recommended in order to reduce brain edema, but the dose and duration of administration in cerebral toxoplasmosis has not been evaluated in a clinical trial. Adjunctive therapy given in cerebral toxoplasmosis patients still remains unclear. Moreover, its safety in immunodeficiency cases is still debatable.

Conditions

  • Toxoplasmosis, Cerebral

Interventions

DRUG

Dexamethasone

Patients in experimental arms will receive i.v. dexamethasone 20 mg (4 ampules = 20mL) for 7 days

DRUG

Placebo

Patients in placebo arms will receive 20 mL normal saline intravenously for 7 days

Sponsors & Collaborators

  • Universitas Padjadjaran

    lead OTHER

Principal Investigators

  • Sofiati Dian, M.D., PhD · Faculty of Medicine Universitas Padjadjaran Bandung

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2025-04-30
Completion
2025-07-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

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 NCT04341155 on ClinicalTrials.gov