SAFETY AND EFFICACY OF AMBISOME VS CONVENTIONAL AMPHOTERICIN B IN THE TREATMENT OF PATIENTS WITH SUSPECTED OR CONFIRMED MYCOSIS

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000596606

Enrollment

104

Registered

2005-10-05

Start date

2007-04-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Systemic treatment of mycosis with either liposomal amphotericin B (AmBisome by Gilead Sciences) or conventional amphotericin B (Fungizone by Bristol-Myers Squibb). Treatment will be given for a minimum of 14 days. However, if the patient's condition deteriorates after 10 days of therapy, the patient will be switched to salvage therapy (AmBisome 5mg/kg/day). TOtal duration of therapy depends on the infection and the patient's condition.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Highly suspected or confirmed invasive fungal infection.

Exclusion criteria

No exclusion criteria

Outcome results