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Completed

NCT Number: NCT00548080

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

Registration study

Completed

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Key information

Conditions

Fungal Infection Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0991, caspofungin acetate / Duration of Treatment:

Drug

Primary outcomes

  1. The proportion of caspofungin-treated patients with SAE

Secondary outcomes

  1. The proportion of caspofungin-treated patients with a favorable efficacy response at the end of caspofungin study therapy

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Oct 23, 2007
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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