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Evaluation and Comparison of Two Different Meropenem Administration Methods in Pediatric Patients with Febrile Neutropenia

Comparison of the Efficacy and Safety of Extended Infusion Versus Intermittent Infusion of Meropenem in Pediatric Patients with Febrile Neutropenia: A Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120731010453N8
Enrollment
100
Registered
2025-10-31
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile neutropenia. Other diseases of blood and blood-forming organs

Interventions

Intervention 1: Intervention group: In this group, meropenem is administered as an extended infusion over 3 hours at a dose of 20 mg/kg every 8 hours. Intervention 2: Control group: In this group, mer

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Children Under 18 Years of Age with Cancer and Febrile Neutropenia Receiving Meropenem for at Least 48 Hours

Exclusion criteria

Exclusion criteria: Hypersensitivity to Meropenem Early death (before 48 hours) Undergoing bone marrow transplantation during the study period

Design outcomes

Primary

MeasureTime frame
Mortality rate. Timepoint: Duration of hospitalization. Method of measurement: By reviewing patient file information.;Length of hospital stay. Timepoint: Duration of hospitalization. Method of measurement: By reviewing patient file information.;Treatment success or failure. Timepoint: Duration of hospitalization. Method of measurement: By reviewing patient file information.;Serum meropenem levels. Timepoint: 4 hours after receiving the third dose of meropenem and immediately before administration of the fourth dose of meropenem. Method of measurement: Serum meropenem levels will be analyzed using HPLC.

Secondary

MeasureTime frame
Adverse events associated with each administration method. Timepoint: Duration of hospitalization. Method of measurement: By reviewing patient file information.;Assessment of the need for changes in the empirical antibiotic regimen or escalation of therapy. Timepoint: Duration of hospitalization. Method of measurement: By reviewing patient file information.;Recurrence of fever within 72 hours after discontinuation of antibiotics. Timepoint: Duration of hospitalization. Method of measurement: By reviewing patient file information.;Response of inflammatory markers, including procalcitonin and CRP. Timepoint: Duration of hospitalization. Method of measurement: By reviewing patient file information.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Shafiekhani

Shiraz University of Medical Sciences

mojtabashafiekhani@gmail.com+98 71 3242 4255

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026