Trial reportJournal of the Pediatric Infectious Diseases Society2025
Pharmacokinetics and Safety of Ceftazidime-Avibactam in Neonates and Young Infants: A Phase 2a, Multicenter Prospective Trial.
Trial report in Journal of the Pediatric Infectious Diseases Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04126031 (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), which is not on this map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
8 citing papers in PubMed.
- Use of Ceftazidime-Avibactam in a Late-Preterm Newborn with Multidrug-ResistantAntibiotics (Basel, Switzerland) · 2026Article
- Antimicrobial Resistance in Pediatric Infections: Current Status, Challenges, and Future Directions.Antibiotics (Basel, Switzerland) · 2026Review
- Clinical and microbiological characteristics of neonates with bacteremia by NDM-producing Klebsiella pneumoniae in a Peruvian referral hospital.Revista peruana de medicina experimental y salud publica · 2026Article
- Use of RESERVE-Antibiotics in Newborns: Clinical Experience of Two NICUs in the Metropolitan Area of Palermo.Antibiotics (Basel, Switzerland) · 2026Article
- Aztreonam-avibactam therapy following surgical source control forFrontiers in pharmacology · 2026Article
- PK/PD-guided ceftazidime-avibactam dosing for multidrug-resistantFrontiers in pharmacology · 2026Article
- Neonatology: First Exposure to Antibiotics from the Ethical Perspective of Parents, Physicians, and Regulators.Antibiotics (Basel, Switzerland) · 2025Article
- Ceftazidime-avibactam for the treatment of multidrug-resistant or extensively drug-resistant bacteria infection in preterm infants: case series study and literature review.Frontiers in pediatrics · 2025Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
backgroundThis phase 2a study evaluated pharmacokinetics and safety of ceftazidime-avibactam (CAZ/AVI; combination dosed as fixed 4:1 ratio) in neonates and young infants with suspected/confirmed infections due to Gram-negative pathogens requiring intravenous antibiotics.
methodsHospitalized neonates and infants (gestational age ≥ 26 weeks to < 3 months), enrolled sequentially into 3 age cohorts, received CAZ/AVI single dose (Part A) or multiple dose every 8 h (Part B) by 2-h intravenous infusions. Infants > 28 days (Cohort 1) received CAZ/AVI 37.5 mg/kg/dose (CAZ 30 mg/kg and AVI 7.5 mg/kg). Full-term neonates ≤ 28 days (Cohort 2) and preterm neonates ≤ 28 days (Cohort 3) received 25 mg/kg/dose (CAZ 20 mg/kg and AVI 5 mg/kg). Pharmacokinetics, safety, and clinical and microbiological outcomes (Part B only) were assessed descriptively.
resultsForty-six patients received CAZ/AVI, 25 in Part A and 21 in Part B. Sepsis (39.1%) and urinary tract infection (15.2%) were the predominant diagnoses. Observed drug plasma-concentration time profiles were generally similar across cohorts. Overall, 23 patients (50%) had ≥ 1 adverse event (AE), 8 patients (17.4%) had ≥ 1 serious AE (SAE), and 2 patients (4.3%) died; no SAE or death was treatment related. In Part B, ≥ 80% of patients had favorable clinical and microbiological responses.
conclusionsPlasma exposures after single and multiple CAZ/AVI doses in neonates and young infants < 3 months old (37.5 [30/7.5] mg/kg/dose for > 28 days; 25 [20/5] mg/kg/dose for ≤ 28 days) were similar to approved doses for older children. The safety profile of CAZ/AVI was as expected based on previous observations. Study funded by Pfizer. Trial registration: NCT04126031.
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