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To assess efficacy of first line novel antibiotic combination that is Ceftazidime Avibactam with or without Aztreonam in high risk febrile neutropenia

Ceftazidime-Avibactum versus Meropenem with or without Colistin as empiric, first-line treatment of high-risk febrile neutropenia- a randomized, controlled trial. - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037636
Enrollment
99
Registered
2021-10-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: D848- Other specified immunodeficiencies

Interventions

Control Intervention1: Aztreonam: Early use of a carbapenem (meropenem or imipenem/cilastatin) in febrile neutropenia is recommended for: high-risk patients (i.e. absolute neutrophil count 500 cells/m

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: age above 18 years Undergoing treatment for hematological malignancies or bone marrow failure syndromes or stem cell transplantation high-risk febrile neutropenia as defined by Neutropenia-ANC 7 days Fever -single oral temperature of 38.3 ? C (101° F) on one occasion or 38 ? C (100.4 ° F) on at least 2 occasions (1 hour apart) and/or significant comorbidities or haemodynamically unstable patients More than 5 days admission in any healthcare facility

Exclusion criteria

Exclusion criteria: Age Pregnant or lactating women Patients being treated with palliative intent

Design outcomes

Primary

MeasureTime frame
Resolution of fever in 72 hoursTimepoint: 72 hours—

Secondary

MeasureTime frame
Change of antibiotic therapy in 96 hours Transfer to ICU Survival at 30 daysTimepoint: 96 hours—

Countries

India

Contacts

Public ContactDR SATEESH KUNIGAL

HCG

drsateesh.s@hcgel.com09686861969

Outcome results

None listed

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