Dexamethasone for Cerebral Toxoplasmosis

NCT ID: NCT04341155

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-16
• Study Completion Date: 2025-07-31

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.

Detailed Description

Steroid produces a raising expression of anti inflammation genes (NF-κB, IκB-α and antagonist receptor IL-1) and inhibits pro inflammation cytokines ( TNF-α and IL-1β). It also works as anti edema by correcting the disrupted blood brain barrier during infection process. Dexamethasone is considered to be chosen in this clinical trial due to the long half life among steroids, the strongest glucocorticoid effect comparing other steroids, and easily prepared and used on daily practice.

There are limited data from using adjunctive steroid for treatment of HIV-associated with cerebral toxoplasmosis. Previous study in France published in 2012 showed steroid did not give any significant improvement for patients' neurological outcome and did not worsen patients' condition such as getting nosocomial infection. Meanwhile comparing previous study by Arens et. al in 2007, there was an increasing mortality rate on adjunctive steroid used in cerebral toxoplasmosis patients.

As result of limited data, our trial is looked forward to answer about the efficacy of dexamethasone treatment in reducing mortality rate of cerebral toxoplasmosis patients.

Conditions

Toxoplasmosis, Cerebral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexamethasone

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Dexamethasone

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Dexamethasone - Phapros; Normal Saline 0,9% - B Braun

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or above.

2. Clinical signs and symptoms compatible to cerebral toxoplasmosis

3. Serology HIV positive

4. Immunoglobulin G anti-toxoplasma titre is positive

5. One or more mass lesions on the neuroradiological finding

6. None or less than 3 days of dexamethasone therapy taken

7. Written informed consent from the patients or from close relatives of the patient if the patient is unconscious.

Exclusion Criteria

1. History of anti-toxoplasmosis administrattion for more than 5 days before recruitment

2. Hypersensitivity or other contraindication to dexamethasone

3. Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sofiati Dian, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Universitas Padjadjaran Bandung

Locations

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Site Status: RECRUITING

Countries

Indonesia

Central Contacts

Ahmad R Ganiem, M.D., PhD

Role: CONTACT

rizalbdg@gmail.com

+62 878 2288 3773

Sofiati Dian, M.D., PhD

Role: CONTACT

sofiatidian@gmail.com

+62 812 2119 519

Other Identifiers

TX-202003.01

Identifier Type: -

Identifier Source: org_study_id