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CompletedNCT00379964Updated Feb 23, 2017

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)

A Phase 3 interventional study of caspofungin acetate in Fungal Infection, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Fungal Infection
03

In context

Mycoses

539 studies on the registry are indexed under Mycoses; 55 are open to participants now.

This study's enrollment of 50 is close to the median of 46 across 358 interventional studies indexed under Mycoses.

Browse Mycoses studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Interventions

  • Drugcaspofungin 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.

    Also known as: MK0991, Cancidas

06

What researchers measure

Primary outcomes

  1. Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy.

    Time frame: during the study drug therapy period plus 14 days posttherapy

Secondary outcomes

  1. 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

    Time frame: 7 days following study therapy

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00379964
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Sep 25, 2006
Start date
Jun 2005
Primary completion
May 2006
Completion
May 2006
Last update
Feb 23, 2017

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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