You are here

Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
Research Site
Little Rock, Arkansas, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-17 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Written informed consent will be obtained from parent(s) or other legally acceptable
representative(s), and informed assent from patient (if age appropriate) will be
obtained

2. Male or female children ages ≥3 months to

3. Hospitalized, receiving systemic antibiotic therapy for the treatment of a suspected
or confirmed infection, and expected to require hospitalization until after the end of
treatment (EOT) evaluations are completed.

4. If female and has reached menarche, or has reached Tanner stage 3 breast development
(even if not having reached menarche), the patient is practicing appropriate birth
control or is sexually abstinent.

5. Likely to survive the current illness or hospitalization.

6. Sufficient intravascular access (peripheral or central) to receive study drug.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin,
other ?-lactam antibiotics.

2. If female, currently pregnant or breast feeding or has a positive serum ?-human
chorionic gonadotropin (?-hCG) pregnancy test.

3. Receipt of a blood or blood component (e.g., red blood cells, fresh frozen plasma,
platelets) transfusion during the 24-hour period before enrolment.

4. BMI outside the range (below the 5th percentile or above the 85th percentile) for
height, age, and weight except for children

5. Babies born prior to 37 weeks gestation (cohort 4 only).

NCT01893346
Pfizer
Completed
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now