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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03003273
Other study ID # IECPG-164
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 2017
Est. completion date December 2018

Study information

Verified date January 2019
Source All India Institute of Medical Sciences, New Delhi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low risk features (culture awaited), will be started on intravenous antibiotics (Inj Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or reappearance of fever within follow-up of ≤ 10 days.


Recruitment information / eligibility

Status Terminated
Enrollment 142
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria:

- All pediatric febrile neutropenia patients treated on outpatient basis

- Age 3 years - 18 years

- Fulfilling low risk criteria ( Hematological malignancies in remission, No identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis / Nausea-vomiting/ neurologic-mental status changes/ Central Venous Catheter (CVC) related infection, Anticipated Absolute Neutrophil Count (ANC) recovery = 10 days, No organ dysfunction, Hemodynamically stable, Culture negative )

- Afebrile for at least 24 hours, on intra-venous antibiotics

Exclusion Criteria:

- Bone marrow involvement in solid tumor

- Already enrolled once, in previous episode

- On antibiotics prophylaxis

- Retroviral positive patients

- Patient undergone stem cell transplant

Study Design


Intervention

Other:
stoppage of antibiotics
antibiotics will be stopped in arm - A on randomization, once child is afebrile for at least 24 hours and fulfills the inclusion criteria.
amoxycillin/clavulanic acid
In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
levofloxacin
In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)

Locations

Country Name City State
India Department of Medical Oncology, AIIMS New Delhi

Sponsors (1)

Lead Sponsor Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment is considered to be successful if the following is attained without changing the regimen - Patient remains afebrile till recovery of ANC =500 •Measure of effect: Proportion of patients afebrile in each arm till ANC = 500 or reappearance of fever during the period = 10 days
Secondary Rate of re-admission till ANC = 500 or reappearance of fever during the period =10 days
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