Dataset Information

Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections.

ABSTRACT:

Background

In premature infants, complicated intraabdominal infections (cIAIs) are a leading cause of morbidity and mortality. Although universally prescribed, the safety and effectiveness of commonly used antibiotic regimens have not been established in this population.

Methods

Infants ≤33 weeks gestational age and <121 days postnatal age with cIAI were randomized to ≤10 days of ampicillin, gentamicin, and metronidazole (group 1); ampicillin, gentamicin, and clindamycin (group 2); or piperacillin-tazobactam and gentamicin (group 3) at doses stratified by postmenstrual age. Due to slow enrollment, a protocol amendment allowed eligible infants already receiving study regimens to enroll without randomization. The primary outcome was mortality within 30 days of study drug completion. Secondary outcomes included adverse events, outcomes of special interest, and therapeutic success (absence of death, negative cultures, and clinical cure score >4) 30 days after study drug completion.

Results

One hundred eighty infants [128 randomized (R), 52 nonrandomized (NR)] were enrolled: 63 in group 1 (45 R, 18 NR), 47 in group 2 (41 R, 6 NR), and 70 in group 3 (42 R, 28 NR). Thirty-day mortality was 8%, 7%, and 9% in groups 1, 2, and 3, respectively. There were no differences in safety outcomes between antibiotic regimens. After adjusting for treatment group and gestational age, mortality rates through end of follow-up were 4.22 [95% confidence interval (CI): 1.39-12.13], 4.53 (95% CI: 1.21-15.50), and 4.07 (95% CI: 1.22-12.70) for groups 1, 2, and 3, respectively.

Conclusions

Each of the antibiotic regimens are safe in premature infants with cIAI.

Clinical trial registration

NCT0199499.

SUBMITTER: Smith MJ

PROVIDER: S-EPMC9844130 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections.

Smith Michael J MJ Boutzoukas Angelique A Autmizguine Julie J Hudak Mark L ML Zinkhan Erin E Bloom Barry T BT Heresi Gloria G Lavery Adrian P AP Courtney Sherry E SE Sokol Gregory M GM Cotten C Michael CM Bliss Joseph M JM Mendley Susan S Bendel Catherine C Dammann Christiane E L CEL Weitkamp Jörn-Hendrik JH Saxonhouse Matthew A MA Mundakel Gratias T GT Debski Julie J Sharma Gaurav G Erinjeri Jinson J Gao Jamie J Benjamin Daniel K DK Hornik Christoph P CP Smith P Brian PB Cohen-Wolkowiez Michael M

The Pediatric infectious disease journal 20210601 6

<h4>Background</h4>In premature infants, complicated intraabdominal infections (cIAIs) are a leading cause of morbidity and mortality. Although universally prescribed, the safety and effectiveness of commonly used antibiotic regimens have not been established in this population.<h4>Methods</h4>Infants ≤33 weeks gestational age and <121 days postnatal age with cIAI were randomized to ≤10 days of ampicillin, gentamicin, and metronidazole (group 1); ampicillin, gentamicin, and clindamycin (group 2) ...[more]

PMID: 33902072

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Project description:BackgroundAntibiotic prescription for respiratory tract infections (RTIs) in children attending primary care centres is almost double that predicted according to bacterial prevalence. Delayed antibiotic prescription (DAP) is designed to deploy a more rational use of antibiotics. While studies have evaluated DAP efficacy and safety for children with RTIs, little research has been conducted on the economic implications.MethodsOur trial compared cost-effectiveness for DAP, immediate antibiotic prescription (IAP), and no antibiotic prescription (NAP) for children aged 2-14 years with acute uncomplicated RTIs attended to in 39 primary care centres in Spain. The main outcome was the incremental cost-effectiveness ratio (ICER), measured in euros per gained quality-adjusted life days (QALDs). Net monetary benefit (NMB) was also calculated as a tool for decision making. The analysis was performed from a societal perspective for a time horizon of 30 days, and included healthcare direct costs, non-healthcare direct and indirect costs, and the antimicrobial resistance (AMR) cost.ResultsDAP was the most cost-effective strategy, even when the cost of AMR was included. QALD values for the three strategies were very similar. IAP compared to DAP was more costly (109.68 vs 100.90 euros) and similarly effective (27.88 vs 27.94 QALDs). DAP compared to NAP was more costly (100.90 vs 97.48 euros) and more effective (27.94 vs. 27.82 QALDs). The ICER for DAP compared to NAP was 28.84 euros per QALD. The deterministic sensitivity analysis indicated that non-healthcare indirect costs had the greatest impact on the ICER. The cost-effectiveness acceptability curve showed that DAP was the preferred option in approximately 81.75% of Monte Carlo iterations, assuming a willingness-to-pay value of 82.2 euros per gained QALD.ConclusionsWhen clinicians are in doubt about whether an antibiotic is needed for children with RTIs attending PC centres, those treated with the DAP strategy will have slightly better efficiency outcomes than those treated with IAP because its costs are lower than those of IAP. DAP is also the most cost-effective strategy over a time horizon of 30 days if AMR is considered, despite higher short-term costs than NAP. However, if in the long term the costs of AMR are larger than estimated, NAP could also be an alternative strategy.Trial registrationThis trial has been registered at www.Clinicaltrialsgov (identifier NCT01800747; Date: 28/02/2013 (retrospectively registered).

Dataset Information

Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections.

Background

Methods

Results

Conclusions

Clinical trial registration

Publications

Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections.

Similar Datasets

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