Safety and Tolerability of Ceftazidime-Avibactam for pediatric patients with suspected or confirmed infections

• Conditions: hospitalized pediatric patients receiving systemic antibiotic therapy for suspected or confirmed infection.; MedDRA version: 14.1Level: LLTClassification code 10021804Term: Infection bacterialSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-001900-13-Outside-EU/EEA
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-05
• Last Update Posted: 10 June 2013

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1.) Male or female children ages =3 months to <18 years 2.) 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 3.) 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 abstinant 4.) Likely to survive the current illness or hospitalization 5.) Sufficient intravascular access (peripheral or central) to receive study drug.
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.) History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other ß-lactam antibiotics 2.) If female, currently pregnant or breast feeding or has a positive serum ß 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 < 2 years of age 5.) Babies born prior to 37 weeks gestation (cohort 4 only).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified