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

NCT02503761 | Completed Phase 3 DMC

• 1 other identifier: 67890
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Late Onset Neonatal Sepsis

Keywords

meropenem; infusion; late-onset sepsis; newborn; management

Outcome Measures

Primary Outcomes (2)

• Clinical outcome

  * Success is defined as complete or partial resolution of leukocytosis, temperature, and clinical signs and symptoms of infection. * Failure consists of persistence or progression of signs and symptoms of infection, development of new clinical findings consistent with active infection, or death from infection.

  15-28 days from Meropenem treatment

• Microbiological outcome

  * Success is defined as eradication of infection or colonization which means detection of a new pathogen from the site of infection during meropenem therapy and no new antibiotic is indicated * Failure is defined as persistence of infection and superinfection which means detection of a new pathogen from the site of infection during meropenem therapy and new antibiotic is indicated.

  7-21 days from Meropenem treatment

Secondary Outcomes (6)

• Meropenem-related length of mechanical ventilation

  0-31 days from Meropenem treatment

• Meropenem-related length of NICU stay

  10 weeks from Meropenem treatment

• NICU mortality

  12 weeks from time of admission

• Duration of meropenem treatment

  3-28 days

• Clinical side effects of meropenem treatment

  3-28 days from meropenem treatment

Study Arms (2)

Infusion arm

ACTIVE COMPARATOR

Infants will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection. Each dose will be infused over four hours.

Drug: Meropenem.

Bolus group

ACTIVE COMPARATOR

Infants will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection. Each dose will be infused over thirty minutes.

Drug: Meropenem.

Interventions

Meropenem. DRUG

Infants in both groups will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection

Bolus group; Infusion arm

Eligibility Criteria

• Age: 3 Days - 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Acute or chronic renal failure
• Hypersensitivity or allergy to meropenem

Sponsors & Collaborators

• Mansoura University: lead

Related Publications (1)

• Shabaan AE, Nour I, Elsayed Eldegla H, Nasef N, Shouman B, Abdel-Hady H. Conventional Versus Prolonged Infusion of Meropenem in Neonates With Gram-negative Late-onset Sepsis: A Randomized Controlled Trial. Pediatr Infect Dis J. 2017 Apr;36(4):358-363. doi: 10.1097/INF.0000000000001445.

  PMID: 27918382 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, PhD

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: July 21, 2015
• Study Start: August 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07