Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia (0991-055)

A Non-Comparative, Multicenter, Open-Label, Study to Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00548080

Enrollment

131

Registered

2007-10-23

Start date

2006-03-31

Completion date

2006-11-30

Last updated

2015-12-17

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

Conditions

Fungal Infection

Brief summary

Registration study

Interventions

DRUGMK0991, caspofungin acetate / Duration of Treatment:

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient has had an absolute neutrophil count \< 500/mm3 for at least 96 hours (the patient must not be expected to recover from neutropenia in the next 48 hours), and has received at least 96 hours of parenteral broad spectrum systemic antibacterial therapy preceding study entry, and patient has fever \>38.0 Degrees Centigrade within the last 24 hours prior to study entry * Appropriate antibiotics are those that provide broad spectrum gram-positive and gram-negative coverage

Exclusion criteria

* Patient has an inadequately managed bacterial infection at the time of enrollment

Design outcomes

Primary

Measure	Time frame
The proportion of caspofungin-treated patients with SAE	—

Secondary

Measure	Time frame
The proportion of caspofungin-treated patients with a favorable efficacy response at the end of caspofungin study therapy	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026