Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
NCT04126031
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
(All Subjects):
1. Evidence of a personally signed and dated informed consent document indicating that the subject's parent(s), legal guardian, or legally acceptable representative has been informed of all pertinent aspects of the study.
2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Male or female neonates and infants with age at Screening:
Cohort 1: Full term infants (gestational age ≥ 37 weeks) with chronological age >28 days to <3 months (<89 days) or pre-term infants with corrected age >28 days to <3 months (<89 days). A maximum of 3 pre-term corrected age infants may be enrolled in each part (A and B) of Cohort 1. Sites will be notified in writing if this limit is reached.
Cohort 2: Full term neonates (gestational age ≥ 37 weeks) from birth to ≤ 28 days.
Cohort 3: Pre-term neonates (gestational age ≥ 26 to <37 weeks) from birth to ≤ 28 days.
Corrected age = Subtract the number of weeks born before 40 weeks of gestation from the chronological age.
for Part B Subjects Only:
1. At study entry, subject has confirmed or strongly suspected infection with a pathogen
known to be resistant to CAZ-AVI or only a Gram-positive pathogen or viral, fungal, or
parasitic pathogens as the sole cause of infection.
2. Confirmed or suspected central nervous system (CNS) infection (eg, meningitis, brain
abscess, subdural abscess).
3. Anticipated need for antibacterial therapy longer than 14 days (eg, osteomyelitis,
endocarditis). This applies to both study treatment with CAZ-AVI as well as adjunctive
IV antibacterial treatment for suspected co infection with Gram-positive organisms or
multi drug resistant Gram-negative organisms.
4. Receipt of more than 24 hours of nonstudy systemic antibacterial treatment for
Gram-negative organisms after culture and before administration of study doses of
CAZ-AVI. Empiric coverage with an aminoglycoside for suspected multidrug resistant
organisms is permitted, provided CAZ-AVI is initiated within 24 hours after culture.
5. Intravenous treatment with chloramphenicol within 24 hours of administration of study
doses of CAZ-AVI.
6. Subject is expected to be discharged less than 48 hours after the start of CAZ-AVI
infusion.
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Descriptive Information | |||||||
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Brief Title ICMJE | Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants. | ||||||
Official Title ICMJE | A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME AND AVIBACTAM IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 3 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT | ||||||
Brief Summary | This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age. In Part A of the study all patients will receive a single dose of ceftazidime-avibactam. In Part B all patients will received multiple doses of ceftazidime-avibactam. Efficacy will be assessed in the infants and neonates receiving multiple doses of ceftazidime-avibactam. | ||||||
Detailed Description | This is a 2-part, Phase 2a, non-randomized, open-label multicenter, multinational study of intravenous ceftazidime-avibactam in hospitalized neonates and infants with suspected or confirmed bacterial infection. In Part A of the study, patients already receiving intravenous antibacterial therapy with another antibiotic will receive a single intravenous dose of ceftazidime-avibactam followed by observation for 48 hours and a Late Follow-Up assessment 4-5 weeks later. In Part B of the study, patients with suspected or confirmed Gram-negative bacterial infections requiring intravenous antibacterial therapy will receive multiple doses of intravenous ceftazidime-avibactam for up to 14 days. At the discretion of the investigator, patients may also receive other antibiotics if the infection is suspected to include Gram-positive bacteria, multi-drug resistant Gram-negative bacteria, or anaerobic bacteria. At the discretion of the investigator, patients may be switched to oral therapy or outpatient parenteral antimicrobial therapy with an alternative antibiotic after receiving intravenous ceftazidime-avibactam for at least 48 yhours. Clinical outcomes will be assessed at the End of Intravenous (EOIV) treatment with ceftazidime-avibactam, the End-of-Therapy (EOT), the Test-of-Cure (TOC) at 7-14 days after the last study therapy and at a Late Follow-Up (LFU) visit, 28-55 days after the last dose of ceftazidime-avibactam. Safety assessments will occur throughout the study. Ceftazidime-avibactam blood levels will be assessed during the first 12 hours after the single dose of ceftazidime-avibactam in Part A and during 12 hours after at least 3 consecutive doses of ceftazidime-avibactam in Part B. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Intervention Model Description: Non-randomized, 2-part with three age cohorts in each part Masking: None (Open Label)Primary Purpose: Basic Science | ||||||
Condition ICMJE | Gram-negative Bacterial Infection | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 48 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | August 23, 2022 | ||||||
Estimated Primary Completion Date | August 23, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria (All Subjects):
Cohort 1: Full term infants (gestational age ? 37 weeks) with chronological age >28 days to <3 months (<89 days) or pre-term infants with corrected age >28 days to <3 months (<89 days). A maximum of 3 pre-term corrected age infants may be enrolled in each part (A and B) of Cohort 1. Sites will be notified in writing if this limit is reached. Cohort 2: Full term neonates (gestational age ? 37 weeks) from birth to ? 28 days. Cohort 3: Pre-term neonates (gestational age ? 26 to <37 weeks) from birth to ? 28 days. Corrected age = Subtract the number of weeks born before 40 weeks of gestation from the chronological age. Inclusion Criteria for Part A Subjects Only: 1. Hospitalized and receiving intravenous antibacterial therapy for the treatment of a suspected or confirmed bacterial infection. Inclusion Criteria for Part B Subjects Only:
Clinical Criteria:
Laboratory Criteria:
Exclusion Criteria (All Subjects):
Exclusion Criteria for Part A Subjects Only:
Exclusion Criteria for Part B Subjects Only:
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Sex/Gender ICMJE |
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Ages ICMJE | up to 88 Days (Child) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Estonia, Greece, Hungary, India, Italy, Philippines, Slovakia, Taiwan, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04126031 | ||||||
Other Study ID Numbers ICMJE | C3591024 2018-002800-16 ( EudraCT Number ) NOOR ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Allergan | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |