A 28 - 90 Days Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Injection as Empirical Therapy in Indian Adults With Persistent Fever and Neutropenia (0991-053)(COMPLETED)

Fungal Infection Clinical Trial

Official title:

A Noncomparative, Multicenter, Open-Label, Study to Evaluate the Safety, Tolerability and Efficacy of MK0991 as Empirical Therapy in Indian Adults With Persistent Fever and Neutropenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379964
• Other study ID #: 0991-053
• Secondary ID: 2006_037
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2006
• Last updated: February 20, 2017
• Start date: June 2005
• Est. completion date: May 2006

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has a low white cell count (less than 500/mm3) for at least 96 hours

• Patient is indian and is greater than 18 years of age

• Patient received chemotherapy for blood disorders and blood cancers

Exclusion Criteria:

• Patient has an invasive fungal infection

• Patient has a bacterial infection that is not controlled

• Patient has allergy to the class of antifungals of study drug

• Patient is not expected to survive at least 5 days

• Patient is pregnant or breast-feeding

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses
• Neutropenia

Intervention

Drug:
• caspofungin acetate
Cancidas 50 mg dose followed by 70 mg load on day 1 was administered in Indian adults with persistent fever and neutropenia for a maximum duration of empirical treatment from 28 days ((for patients without documented infection) to 90 days (for patients with documented baseline or emergent fungal infection). Patients were treated until the resolution of neutropenia (ANC>500/mm3), and for up to 72 hours later.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy.		during the study drug therapy period plus 14 days posttherapy
Secondary	Survival for at least 7 days following study therapy reduce fever during period of low white blood cell counts fungal infection no longer present following study therapy		7 days following study therapy