Bacterial Pneumonia, Soft Tissue Infections, Urinary Tract Infections
Conditions
Brief summary
This study will investigate the safety and efficacy of ertapenem versus ceftriaxone in pediatric patients with urinary tract infections, skin infections, or community-acquired pneumonia.
Interventions
DRUGMK0826, ertapenem sodium /Duration of Treatment: 14 Days
DRUGComparator: ceftriaxone sodium /Duration of Treatment: 14 Days
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients with UTI must have white blood cells and bacteria in the urine with bladder catheterization or urologic abnormality, kidney infection or both * Patients with SSTI must have a recent infection * Patients with CAP must have a chest x-ray indicating bacterial pneumonia and a fever
Exclusion criteria
* Patients with complete urinary tract blockage or kidney abscess * Patients with infected burn wounds, bone infection, or bacterial arthritis * Patients on mechanical ventilation or those with cystic fibrosis, chronic lung disease or puss in the space between the chest wall and lung
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the incidence of any clinical and/or laboratory drug-related serious adverse experience during the parenteral therapy period in pediatric patients treated with ertapenem. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the safety of ertapenem versus ceftriaxone during the parenteral therapy period with respect to the proportion of patients with any drug-related adverse experiences in pediatric patients with UTI, SSTI, or CAP. | — |
Outcome results
None listed