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Anti-fungal

CAMB (Encochleated Amphotericin B) for Oral Thrush (CAMB Trial)

Phase 2
Waitlist Available
Led By Alexandra Freeman, MD
Research Sponsored by Matinas BioPharma Nanotechnologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
No Placebo-Only Group

Summary

This is an open-label, dose-titration trial to study the efficacy, safety, and pharmacokinetics of oral cochleate amphotericin B (CAMB) in the treatment of mucocutaneous candidiasis infections in patients who are refractory or intolerant to standard non intravenous therapies.

Eligible Conditions
  • Oral Thrush
  • Chronic Mucocutaneous Candidiasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Response to Treatment of Mucocutaneous Candidiasis
Secondary study objectives
Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Postdose
Long-term Adverse Events, Changes in Laboratory Parameters
Maximum Plasma Concentration (Cmax)
+1 more
Other study objectives
Long-term adverse events, changes in laboratory parameters
Candidiasis, Chronic Mucocutaneous

Side effects data

From 2008 Phase 2 trial • 143 Patients • NCT00145249
80%
Hypokalaemia
63%
Hypomagnesaemia
49%
Anaemia
33%
Vomiting
33%
Nausea
29%
Headache
22%
Insomnia
18%
Constipation
16%
Phlebitis
14%
Anorexia
12%
Thrombophlebitis
12%
Pyrexia
12%
Hyponatraemia
12%
Diarrhoea
12%
Sepsis
12%
Sinusitis
10%
Rash
10%
Herpes simplex
10%
Bacteraemia
8%
Oral candidiasis
8%
Upper respiratory tract infection
8%
Thrombocytopenia
6%
Asthenia
6%
Neutropenia
6%
Depression
6%
Papilloedema
6%
Rash papular
6%
Dehydration
6%
Pruritus
6%
Hyperkalaemia
4%
Intracranial pressure increased
4%
Cough
4%
Convulsion
4%
Hypotension
4%
Blood creatinine increased
4%
Hypertension
4%
Chills
4%
Respiratory failure
2%
Cerebral haemorrhage
2%
Subdural haematoma
2%
Meningitis cryptococcal
2%
Escherichia sepsis
2%
CSF pressure increased
2%
Hepatitis
2%
Pain in extremity
2%
Pneumocystis jiroveci pneumonia
2%
AIDS related complication
2%
Cardiac failure congestive
2%
Psychotic disorder
2%
Central nervous system lymphoma
2%
Immune reconstitution syndrome
2%
Toxoplasmosis
2%
Cardio-respiratory arrest
2%
Congestive cardiomyopathy
2%
Prothrombin time prolonged
2%
Pseudomonal bacteraemia
2%
Back pain
2%
Pneumonia
2%
Herpes zoster
2%
Cerebral infarction
2%
Cachexia
2%
Cholangitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
AmphoB + Fluc800
AmphoB Standard
AmphoB+Fluc400

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CAMB (Encochleated Amphotericin B)Experimental Treatment1 Intervention
Encochleated Amphotericin B (200 mg, 400 mg, 800 mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amphotericin B
2010
Completed Phase 4
~1050

Find a Location

Who is running the clinical trial?

Matinas BioPharma Nanotechnologies, Inc.Lead Sponsor
7 Previous Clinical Trials
685 Total Patients Enrolled
Alexandra Freeman, MDPrincipal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
~0 spots leftby Nov 2025
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