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Study aim
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Comparison of mean length of hospital stay between the ceftriaxone and aminoglycoside group with the cefpime group
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Design
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Clinical trial with control group, parallel, single blind, randomized, phase 3 with 60 episodes of fever and neutropenia. Sealedenvelop.com was used for randomization.
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Settings and conduct
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Motahhari Children's Hospital in Urmia, children with fever and neutropenia due to chemotherapy, children are divided into two groups: Motahhari and American Society of Clinical Oncology and tests are taken. In patients whose culture is positive during the study, the antibiotic regimen will be readjusted according to the culture result. Also, if there is no clinical improvement after 72 hours, the patient's antibiotics will change to a higher level of microbial coverage, and in case of deterioration after 96 hours, antifungal will be added to the treatment regimen. Data analyzer is blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1- Age between 3 months to 18 years
2- Diagnosis of fever and neutropenia (oral temperature ≥ 38.3 at one measurement or ≥38 temperature that lasts for one hour, with 500 ANC <)
3- Cancer
4- Consent of the parent or legal guardian to participate in the study protocol
5- No contraindications for receiving the studied antibiotics (gentamicin, amikacin, ceftrixone, cefpime)
Inclusion criteria:
1- Patients with a history of type 1 allergy to one of the above antibiotics
3- Patients who have a specific microorganism at the beginning of the culture
2- Critical patients who need extensive antibiotic coverage from the beginning of hospitalization
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Intervention groups
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Motahhari (M) group: gentamicin/amikacin +ceftriaxone
ASCO (A) group: cefepime
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Main outcome variables
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Mean duration of ICU and hospital stay, frequency of need to escalate antibiotic regimen, mean duration required to stop fever, mean changes in laboratory data