NCT00847678

Brief Summary

This is a multicenter, randomized, efficacy and safety trial to evaluate Mycograb®. Subjects will be randomized to one of the 3 arms: 1/ Amphotericin B (0.7 mg/kg/d) plus 5-flucytosine (100 mg /kg/d); 2/ Amphotericin B plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days); 3/ Amphotericin B plus 5-flucytosine plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days). After 2 weeks, all patients will be switched to fluconazole at 400 mg/d for 8 weeks and 200 mg/d thereafter. The total duration of the study will be approximately 24 months

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

Enrollment Period

1.3 years

First QC Date

February 18, 2009

Last Update Submit

February 18, 2009

Conditions

Cryptococcal Meningitis

Keywords

Cryptococcal Meningitis

Outcome Measures

Primary Outcomes (1)

  • proportion of patients (receiving Mycograb + Amphotericin B + 5-flucytosine) cured (combined clinical and microbiological response) versus placebo (Amphotericin B + 5-flucytosine) and versus Mycograb + Amphotericin B alone.

    day 14

Secondary Outcomes (3)

  • Safety of Mycograb versus placebo. Safety assessment will include: physical examination, vital signs, laboratory parameters, adverse events, serious adverse events.

    week 10

  • Assess the cerebrospinal fluid (CSF) penetration of Mycograb

    Days 3, 7 and 14

  • Determine whether Mycograb + Amphotericin B is as effective as Amphotericin B plus 5-cytosine while avoiding the potential problem of 5-cytosine toxicity.

    Day 14

Study Arms (3)

1

EXPERIMENTAL

Mycograb + Amphotericin B + 5 flucytosine

Biological: Efungumab (Mycograb)Biological: Amphotericin BBiological: 5 flucytosine

2

PLACEBO COMPARATOR

Placebo + Amphotericin B + 5 flucytosine

Biological: placeboBiological: Amphotericin BBiological: 5 flucytosine

3

EXPERIMENTAL

Mycograb + Amphotericin B

Biological: Efungumab (Mycograb)Biological: Amphotericin B

Interventions

Efungumab (Mycograb)BIOLOGICAL
13
placeboBIOLOGICAL
2
Amphotericin BBIOLOGICAL
123
5 flucytosineBIOLOGICAL
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant female who is \> 18 years old.
  • HIV-positive or unknown, with acute, either first or recurrent episode of cryptococcal meningitis.
  • Currently on no treatment, or receiving treatment (\< 3 days) with either amphotericin B plus 5-flucytosine, or amphotericin B alone.
  • Positive CSF culture for Cryptococcus neoforman.
  • Physical signs and symptoms of meningitis, evidenced by one or more of the following: fever, headache, meningeal signs and neurologic findings.

You may not qualify if:

  • Excluded for coma, or significant other medical conditions.
  • Subject has other opportunistic fungal infections that requires other systemic antifungal therapies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

South Africa, South Africa

Location

MeSH Terms

Conditions

Meningitis, Cryptococcal

Interventions

efungumabAmphotericin BFlucytosine

Condition Hierarchy (Ancestors)

Meningitis, FungalCentral Nervous System Fungal InfectionsMycosesBacterial Infections and MycosesInfectionsCryptococcosisCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsCytosinePyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

August 1, 2006

Primary Completion

November 1, 2007

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

ZA(1)