Dexamethasone for Cerebral Toxoplasmosis

NCT04341155 | Recruiting Phase 2 DMC

• 1 other identifier: TX-202003.01
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mortality

  Determined by the time from randomization to death (in days)

  90 days

Secondary Outcomes (7)

• Number of participants with grade 3 and 4 and serious adverse events related to study drug

  7 days

• Changes in consciousness

  14 days

• Neurological response (1)

  up to 90 days

• Neurological response (2)

  up to 90 days

• Cognitive function (1)

  up to 90 days

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Sixty nine patients will be administered randomly dexamethasone 20 mg IV for 7 days. Along with study drug or placebo, patients will receive standard anti toxoplasmosis (Oral pyrimethamine 150 or 200 mg (according to body weight) for three days continued by 50 or 75mg (according to body weight) per day or oral cotrimoxazole 2 x 1920 mg; oral clindamycin 600mg q.i.d) in accordance to national neurologist association guidelines.

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Sixty nine patients will be administered randomly Normal Saline 0,9% IV (4 cc) for 7 days. Along with study drug or placebo, patients will receive standard anti toxoplasmosis (Oral pyrimethamine 150 or 200 mg (according to body weight) for three days continued by 50 or 75mg (according to body weight) per day or oral cotrimoxazole 2 x 1920 mg; oral clindamycin 600mg q.i.d) in accordance to national neurologist association guidelines.

Drug: Placebo

Interventions

Dexamethasone DRUG

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

Also known as: Dexamethasone - Phapros

Dexamethasone

Placebo DRUG

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

Also known as: Normal Saline 0,9% - B Braun

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above.
• Clinical signs and symptoms compatible to cerebral toxoplasmosis
• Serology HIV positive
• Immunoglobulin G anti-toxoplasma titre is positive
• One or more mass lesions on the neuroradiological finding
• None or less than 3 days of dexamethasone therapy taken
• Written informed consent from the patients or from close relatives of the patient if the patient is unconscious.

You may not qualify if:

• History of anti-toxoplasmosis administrattion for more than 5 days before recruitment
• Hypersensitivity or other contraindication to dexamethasone
• Pregnancy

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

RECRUITING

MeSH Terms

Conditions

Toxoplasmosis, Cerebral

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Brain Abscess; Central Nervous System Infections; Infections; Central Nervous System Protozoal Infections; Central Nervous System Parasitic Infections; Parasitic Diseases; Toxoplasmosis; Coccidiosis; Protozoan Infections; Abscess; Suppuration; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Sofiati Dian, M.D., PhD

  Faculty of Medicine Universitas Padjadjaran Bandung

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad R Ganiem, M.D., PhD

CONTACT

+62 878 2288 3773; rizalbdg@gmail.com

Sofiati Dian, M.D., PhD

CONTACT

+62 812 2119 519; sofiatidian@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 10, 2020
• Study Start: April 16, 2021
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

ID (1)