Meningitis, CryptococcalPhase 2NCT00000776
Dexamethasone in Cryptococcal Meningitis
A Phase 2 study testing Flucytosine, Fluconazole and Amphotericin B in people with Meningitis, Cryptococcal and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in 2 countries.
Trial summary
To evaluate the effect of corticosteroids on reducing elevated intracranial pressure in cryptococcal meningitis. To evaluate the safety of corticosteroids in patients with cryptococcal meningitis and intracranial hypertension. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Meningitis, Cryptococcal, HIV Infections
- What is being tested?
- Flucytosine, Fluconazole and Amphotericin B
- How many people
- 36 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Start not givento Sep 1996
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Aerosolized pentamidine or systemic chemoprophylaxis for PCP.
- Preventive therapy for steroid-associated ulcers and any other therapies required to manage steroid toxicity (e.g., insulin).
- Patients must have:
- Documented initial episode or relapse of acute cryptococcal meningitis. (NOTE: Patients must be untreated for this episode except for administration of a test dose of 1 g or less amphotericin B.)
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- Acute cryptococcal meningitis with cerebrospinal fluid opening pressure >= 250 mm H2O prior to receipt of antifungal therapy for this episode.
- Documented HIV infection OR a diagnosis of AIDS based on a documented AIDS-defining opportunistic infection.
- Ability to begin therapy within 8 hours after the pre-entry lumbar puncture.
- Consent of parent or guardian if less than 18 years of age.
- NOTE:
- Comatose patients eligible provided informed consent can be provided by guardian or next of kin.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Concurrent CNS disease such as another infection or neoplasm that would interfere with assessment of response.
- Prison incarceration.
- Concurrent Medication:
- Excluded:
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- Acetazolamide, mannitol, urea preparations, and other corticosteroids during the first 72 hours of the study.
- Treatment or prophylaxis with other systemic antifungal agents at any time.
- Antiretroviral therapy during the first 72 hours of the study.
- Prior Medication:
- Excluded within 7 days prior to study entry:
- Corticosteroids, mannitol, urea preparations, acetazolamide, or more than 24 hours of phenytoin.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Northwestern Univ Med School
Chicago, Illinois, 60611
Cook County Hosp
Chicago, Illinois, 60612
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Univ of Miami School of Medicine
Miami, Florida, 331361013
Beth Israel Med Ctr
New York, New York, 10003
Mount Sinai Med Ctr
New York, New York, 10029
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
About this study
To evaluate the effect of corticosteroids on reducing elevated intracranial pressure in cryptococcal meningitis. To evaluate the safety of corticosteroids in patients with cryptococcal meningitis and intracranial hypertension.
In AIDS patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. Since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS patients with cryptococcal meningitis.
Read the detailed description
In AIDS patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. Since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS patients with cryptococcal meningitis.
Patients are randomized to receive dexamethasone or placebo every 6 hours for 72 hours (days 1 through 3). Additionally, standard antifungal therapy with amphotericin B and flucytosine is given for 2 weeks, followed by fluconazole for 8 weeks. Lumbar punctures will be performed daily on days 1 through 3, on days 7 and 14, and at week 10.
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Being tested
- Flucytosine, Fluconazole, Amphotericin B, Dexamethasone
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Dexamethasone, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome, Amphotericin B, Brain Diseases
- Medical subject headings
- Meningitis, Cryptococcal, HIV Infections, AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Acquired Immunodeficiency Syndrome, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlucytosineDrug
FluconazoleDrug
Amphotericin BDrug
DexamethasoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionSep 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningitis, CryptococcalStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- J Jacobson, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000776
- Sponsor's protocol ID
- ACTG 202
- Other IDs
- 11178
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 28 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone in Cryptococcal Meningitis
- ClinicalTrials.gov ID
- NCT00000776
- Acronym / sponsor ID
- ACTG 202
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Dexamethasone, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Sep 1996 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of corticosteroids on reducing elevated intracranial pressure in cryptococcal meningitis. To evaluate the safety of corticosteroids in patients with cryptococcal meningitis and intracranial hypertension.
In AIDS patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. Since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS patients with cryptococcal meningitis.
Detailed description
In AIDS patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. Since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS patients with cryptococcal meningitis.
Patients are randomized to receive dexamethasone or placebo every 6 hours for 72 hours (days 1 through 3). Additionally, standard antifungal therapy with amphotericin B and flucytosine is given for 2 weeks, followed by fluconazole for 8 weeks. Lumbar punctures will be performed daily on days 1 through 3, on days 7 and 14, and at week 10.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Aerosolized pentamidine or systemic chemoprophylaxis for PCP.
- Preventive therapy for steroid-associated ulcers and any other therapies required to manage steroid toxicity (e.g., insulin).
- Documented initial episode or relapse of acute cryptococcal meningitis. (NOTE: Patients must be untreated for this episode except for administration of a test dose of 1 g or less amphotericin B.)
- Acute cryptococcal meningitis with cerebrospinal fluid opening pressure >= 250 mm H2O prior to receipt of antifungal therapy for this episode.
- Documented HIV infection OR a diagnosis of AIDS based on a documented AIDS-defining opportunistic infection.
Key exclusion criteria (12 listed)
- Concurrent CNS disease such as another infection or neoplasm that would interfere with assessment of response.
- Prison incarceration.
- Acetazolamide, mannitol, urea preparations, and other corticosteroids during the first 72 hours of the study.
- Treatment or prophylaxis with other systemic antifungal agents at any time.
- Antiretroviral therapy during the first 72 hours of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flucytosine | Drug | – |
| Fluconazole | Drug | – |
| Amphotericin B | Drug | – |
| Dexamethasone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Jacobson study chair
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flucytosine, Fluconazole and Amphotericin B in people with Meningitis, Cryptococcal and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.