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Comparison of cefpime with a combination of gentamicin or amikacin and ceftriaxone in chemotherapy-induced fever in children

Comparison of clinical outcomes of treatment with cefepime monotherapy vs aminoglycoside-ceftriaxone combination in children with chemotherapy induced fever and neutropenia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151205025372N3
Enrollment
60
Registered
2021-11-10
Start date
2021-10-23
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

fever and neutropenia due to chemotherapy. Agranulocytosis secondary to cancer chemotherapy

Interventions

Intervention 1: Intervention group: Cefpime 50mg / kg every eight hours. Intervention 2: Control group: aminoglycoside (gentamicin 2-2.5 mg / kg every eight hours / amikacin 15-22.5 mg / kg daily in t

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Months to 18 Years

Inclusion criteria

Inclusion criteria: Age between 3 months to 18 years Diagnosis of fever and neutropenia (oral temperature = 38.3 at one measurement or =38 temperature that lasts for one hour, with ANC <500 ) Cancer Consent of the parent or legal guardian to participate in the study protocol No contraindications for receiving the studied antibiotics (gentamicin, amikacin, ceftriaxone, cefepime)

Exclusion criteria

Exclusion criteria: Patients with a history of type 1 allergy to one of the above antibiotics Patients who have a positive culture with specific microorganism on admission Patients in need who need extensive antibiotic coverage from the beginning of hospitalization

Design outcomes

Primary

MeasureTime frame
Mean hosptial stay. Timepoint: After discharge. Method of measurement: Counting days.;Mean ICU stay. Timepoint: After discharge. Method of measurement: Counting days.;Frequency of the need to escalate the antibiotic regimen. Timepoint: After discharge. Method of measurement: Checking the patient's file.;The mean duration required to stop the fever. Timepoint: After discharge. Method of measurement: Counting days.

Secondary

MeasureTime frame
Mean ICU stay. Timepoint: After discharge. Method of measurement: Counting days.;Frequency of the need to escalate the antibiotic regimen. Timepoint: After discharge. Method of measurement: Checking the patient's file.;The mean duration required to stop the fever. Timepoint: After discharge. Method of measurement: Counting days.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Alimohammad Ghelichkhan

Oroumia University of Medical Sciences

z.gkhan@yahoo.com+98 44 3275 4991

Outcome results

None listed

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