CRITIC - Treatment of Candidemia and Invasive Candidiasis

Gilead Sciences

Status and phase

Completed

Phase 4

Conditions

Candidemia

Invasive Candidiasis

Treatments

Drug: AmBisome

Study type

Interventional

Funder types

Industry

Identifiers

NCT00670657

GS-IT-131-0177

Details and patient eligibility

About

Patients will receive 2mg/kg/day IV daily administration of AmBisome® over 30-60 minutes as a reaction to signs/symptoms and positive Candida culture

Full description

Subjects will be enrolled to receive intravenously AmBisome® at 2 mg/kg/day for a maximum of 4 weeks. Treatment will be discontinued in case of failure, adverse events precluding treatment or success. In case of success AmBisome® at 2 mg/kg/day should be administered for at least 5 days after the complete resolution of all clinical findings of an active infection or for at least 8 days after the last positive blood culture or culture from a normally sterile site. It is not recommended to declare failure (and therefore change treatment) before giving at least 5 days of antifungal therapy. Failures in patients given less than 5 days of treatment should be well documented (e.g. persistent positive cultures despite catheter removal, clinical deterioration in absence of any explanation other than the fungal infection). Follow-up evaluations will be conducted at 2 and 4 weeks after the end of AmBisome® therapy. At end of treatment (time point for success or failure) patients may be shifted to oral (not intravenous) antifungals at the discretion of the local investigator, once a complete response has been achieved, if secondary prophylaxis is deemed necessary.

Enrollment

39 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients admitted to ICU for all medical reasons that meet the inclusion criteria
Males or non pregnant females (women of child-bearing potential must have a negative serum or urine pregnancy test at baseline).
Subjects who are 14 years old or older.
Subjects with at least one positive blood culture isolation of a Candida spp. from a specimen or from a normally sterile site (including abdominal catheters), drawn within 96 hours prior to study entry.
Subjects who have clinical evidence of infection AT SOME TIME WITHIN 48 HOURS PRIOR TO ENROLLMENT, including AT LEAST ONE of the following:
1. temperature> 38°C on 2 occasions at least 4 hours apart or one determination greater than 38.5°C (internal, at oesophagus, tympani or bladder levels).
2. systolic blood pressure < 90, or a >30 mm Hg decrease in systolic BP from the subject's normal baseline.
3. Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida
Subjects or their legal representative (but the subject should sign it in any case when able to) must sign a written informed consent form. Written informed consent must be obtained before any study-related procedure is carried out.

Exclusion criteria

Subjects with a history of allergy or intolerance to AmBisome®
Subjects who have received systemic antifungal therapy within 15 days prior to inclusion in the study
Any severe cardiovascular disease (such as arrhythmias, in particular) which may constitute a contra-indication to AmBisome® administration
Subjects with an absolute neutrophil count of less than 500/mm3 in the 48 hours before enrolment in the study
Subjects with a diagnosis of AIDS (positive HIV serology in association with either CD4 cell counts < 200 cells/mm3or history of an opportunistic infection /neoplasm), aplastic anemia, or Chronic Granulomatous Disease.
Subjects with moderate or severe liver disease defined as any one or more of the following:

* Alkaline phosphatase, ALT, AST, or total bilirubin greater than 5 times the ULN (upper limit of normal)
Subjects with a severe renal impairment defined by a serum creatinine of more than 2.5 mg/dL.
Women who are pregnant or breastfeeding.
Subjects who are unlikely to survive more than 24 hours.
Subjects who previously participated in this study.
Subjects who have received within the two weeks before study entry, are receiving or likely to receive any investigational drug (unlicensed new chemical entity).