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Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis

Information source: Mansoura University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Late Onset Neonatal Sepsis

Intervention: Meropenem. (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Mansoura University

Summary

Newborns in the neonatal intensive care unit (NICU), especially premature ones with immature organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to narrow-spectrum antibiotics like ampicillin and gentamicin and require introduction of new agents with a wider spectrum of activity. Meropenem has activity against wide variety of Gram-negative and Gram-positive bacteria. It is well tolerated by children and neonates, including preterm babies, and allowing monotherapy instead of combined therapy. Severe neonatal infections with increasing antibiotic resistance are major problems affecting morbidity and mortality in the NICU. Few number of new antibacterial agents entering the clinic and new agents for multi-drug resistant Gram-negative bacteria will unlikely be available in the near future.

Clinical Details

Official title: Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis: A Randomized Control Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Clinical outcome

Microbiological outcome

Secondary outcome:

Meropenem-related length of mechanical ventilation

Meropenem-related length of NICU stay

NICU mortality

Duration of meropenem treatment

Clinical side effects of meropenem treatment

Laboratory derangement related to meropenem treatment

Detailed description: More research into existing antibiotics with novel mechanisms of action are required to combat the increased resistance and decreased development of antibiotics. Efforts were exerted to maximize antibiotic efficacy by optimal dosing based on pharmacodynamic and pharmacokinetic properties of antibiotics. Meropenem is administered mostly via a 30-min infusion, as some data indicate rapid degradation after reconstitution. Dose recommendations from two pediatric studies using Monte Carlo simulation have emphasized that a 4-h infusion may be needed if microorganisms showed increased minimal inhibitory concentrations (MICs), more specifically, for Pseudomonas aeruginosa. A prolonged-infusion strategy has not been tested in neonates, although some data suggest that extremely small infusion volumes may significantly affect the drug amount actually delivered. Aim of work: The objective of our study is to compare the clinical and bacteriological efficacy of conventional intermittent dosing of meropenem to the prolonged infusions in critically-ill neonates, with a proactive focus on reducing ventilator days in ventilated patients, length of stay in NICU, and neonatal mortality.

Eligibility

Minimum age: N/A. Maximum age: 4 Weeks. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Neonates admitted to the neonatal care unit (NCU) who suffer from late onset sepsis

(LOS) at admission or during their NICU stay and receive meropenem for at least four days Exclusion Criteria:

- Acute or chronic renal failure

- Hypersensitivity or allergy to meropenem

Locations and Contacts

Additional Information

Starting date: August 2013
Last updated: July 17, 2015

Page last updated: August 23, 2015

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