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Cryptococcal MeningitisPhase 2/3FlucocryptoNCT01715922

Study Evaluating Efficiency and Tolerance of High-dose Fluconazole Associated With Flucytosine as Induction Therapy for Cryptococcal Meningitis Associated With HIV in Sub-saharan Africa

A Phase 2/3 study testing Fluconazole, Flucytosine and lumbar punctures in people with Cryptococcal Meningitis and HIV, run by ANRS, Emerging Infectious Diseases at 7 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the trial is to demonstrate that in a sub-Saharan African setting, the association of: 1. Oral treatment : high dose of fluconazole (1600mg/d) associated with flucytosine (100 mg/kg/j) as induction therapy 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cryptococcal Meningitis, HIV
What is being tested?
Fluconazole, Flucytosine and lumbar punctures
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
7 sitesin 2 countries
Study dates
May 2012to Sep 2016
Phase
Phase 2/3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > 18 years
  • HIV Infection
  • First episode of cryptococcal meningitis on basis CSF India ink and/or CSF cryptococcal antigen.
  • Glasgow > 9 after lumbar punctures
  • Absence of peripheral focal deficit in the limbs
  • informed consent signed

Who cannot join

  • Hemoglobin <7.5 g / dl;
  • neutrophils count <500/mm3;
  • Platelets count <50 000/mm3;
  • transaminases > 5 times upper limit of normal;
  • Troubles with severe mental alertness Glasgow <9 after the initial lumbar puncture;
  • focal neurological deficit in the limbs;
Show all 11Show fewer
  • Pregnancy or lactation on going;
  • Ongoing systemic antifungal treatment;
  • History of cryptococcal meningitis;
  • Ongoing rifampicin and ritonavir treatment;
  • Subject participating in another study with a risk of mutual interference on the interpretation of results.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Burundi5 sites

  • CHU Kamenge

    Bujumbura

  • Hôpital Prince Régent Charles

    Bujumbura

  • Hôpital général

    Bururi

  • Hôpital général

    Kayanza

  • Hôpital général

    Muyinga

Côte d’Ivoire2 sites

  • Service de Maladies Infectieuses & Tropicales - Hôpital Triechville

    Abidjan

  • Service de Neurologie - Hôpital Cocody

    Abidjan

Other trials in Côte d’Ivoire

About this study

Official title: Prospective Pilot Study to Evaluate a Standardized Management of Cryptococcal Meningitis in Patients Infected With HIV in Sub-Saharan Africa Involving an Initial Combination Therapy With Fluconazole and Flucytosine in High Doses, Complemented by Repeat Lumbar Punctures

The aim of the trial is to demonstrate that in a sub-Saharan African setting, the association of:

  1. Oral treatment : high dose of fluconazole (1600mg/d) associated with flucytosine (100 mg/kg/j) as induction therapy
  2. lumbar punctures to control intracranial pressure can decrease mortality rate below 35% at 10 weeks.

This is a non-randomized open label pilot study, with standardized management of cryptococcoses meningitis and follow-up in Burundi and Ivory Coast. A total of 41 patients will be enrolled.

Being tested
Fluconazole, Flucytosine, lumbar punctures
Keywords
Cryptococcal meningitis, HIV Infections, Oral treatment, High dose of fluconazole, Flucytosine, Burundi, Ivory Coast
Medical subject headings
Meningitis, Cryptococcal, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluconazoleDrug

    Induction treatment for 2 weeks: Fluconazole (1600mg/j) Consolidation treatment for 8 weeks: fluconazole (800 mg/j)

  • FlucytosineDrug

    Flucytosine (100 mg/kg/j) for 2 weeks

  • lumbar puncturesProcedure or surgery

    lumbar punctures to control intracranial pressure

Study groups in NCT01715922
Study groupRoleWhat they receive
oral treatmentOtherDrug: Fluconazole and flucytosine Induction treatment for 2 weeks: Fluconazole (1600mg/j) + flucytosine (100 mg/kg/j) lumbar punctures to control intracranial pressure Consolidation treatment for 8 weeks: fluconazole (800 mg/j)
Receives: Drug: Fluconazole; Drug: Flucytosine; Procedure: lumbar punctures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality rate

    Measured: 10 weeks

Secondary outcomes (16)

  1. Mortality rate

    Measured: 14 days and 24 weeks

  2. Percentage of patients with negative cerebrospinal fluid (CSF) cultures

    Measured: 14 days and 10 weeks

  3. Number of relapses of cryptococcal throughout the monitoring period

    Measured: up to 24 weeks

  4. Number of "Immune Reconstitution Inflammatory Syndrome" (IRIS) throughout the monitoring period

    The IRIS diagnosis criteria will be those given in: Bicanic T, et al. Immune Reconstitution Inflammatory Syndrome in HIV-associated cryptococcal meningitis: a prospective study, J Acquir Immune Defic Syndr 2009; 51:130-134.

    Measured: up to 24 weeks

  5. Number and severity of adverse events

    Measured: up to 24 weeks

  6. Cerebrospinal fluid pressure evolution

    Measured: up to 24 weeks

  7. Percentage of patients with undetectable viral load

    Measured: 24 weeks

  8. CD4 count

    Measured: 24 weeks

  9. Concentration of flucytosine in cerebrospinal fluid

    Measured: 28 days or 10 weeks

  10. Sensitivity of cryptococcal antigen by strip method LFA (lateral-flow immunoassay)

    on urines, plasma, CSF and whole blood fingerstick

    Measured: at study entry

  11. CSF total volume discharged

    Measured: up to 24 weeks

  12. Number of lumbar punctures performed

    Measured: up to 24 weeks

  13. Concentration of fluconazole in plasma

    Measured: 28 days or 10 weeks

  14. Concentration of fluconazole in cerebrospinal fluid

    Measured: 28 days or 10 weeks

  15. Concentration of flucytosine in plasma

    Measured: 28 days or 10 weeks

  16. MICs of fluconazole

    MICs of fluconazole for cryptococcus strains, if CSF cultures ar positive at 28 days or 10 weeks or in case of relapse

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionSep 2015
  4. Study completionSep 2016 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01715922
Sponsor's protocol ID
ANRS 12257 Flucocrypto
Acronym
Flucocrypto
Status last verified
Jul 2016
First submitted
19 Oct 2012
Last updated
12 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Fluconazole, Flucytosine and lumbar punctures in people with Cryptococcal Meningitis and HIV, run by ANRS, Emerging Infectious Diseases at 7 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Burundi, Côte d’Ivoire. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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.

What does the primary outcome measure?

Mortality rate (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01715922.

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 12 Jul 2016.

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