Fungal Infection
Conditions
Brief 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.
Interventions
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.
Sponsors
Merck Sharp & Dohme LLC
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
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed