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NOT YET RECRUITING
NCT07483736
PHASE3

Efficacy of an Empirical Treatment With Amoxicillin-clavulanate (AC) Compared to the Combination Amoxicillin-clavulanate and Ciprofloxacin (AC+C) in the Outpatient Care of Chemotherapy-induced Fever in Adult Haematology Patients.

Sponsor: Versailles Hospital

View on ClinicalTrials.gov

Summary

The combination of amoxicillin-clavulanate (AC) and a fluoroquinolone (FQ) is currently recommended for the treatment for outpatients with hematologic malignancies presenting with chemotherapy-induced fever (CIF), if the expected duration of neutropenia is \< 7 days. However, infections due to Pseudomonas aeruginosa (naturally resistant to AC) are rare in this population. Furthermore, FQ might result in severe adverse events, and to the selection of bacterial resistance. The investigators hypothesize that monotherapy with AC is non-inferior to the reference treatment AC + FQ in the outpatient treatment of CIF in adult hematology patients. Method: Pragmatic, multicentre, randomized clinical trial, controlled in two parallel groups, with stratified randomization according to the type of haematological disorder. The study will include 1,526 adult patients with one of the following haematological disorders: (1) lymphoma of all histology types treated with the goal of remission; (2) myelodysplasia treated with azacytidine; (3) acute myeloblastic leukemia receiving non-intensive care, with a basal neutrophils count \> 1000/mm3. The participants will be randomized prior to chemotherapy to receive either Amoxicillin-clavulanate 1g/152 mg tid. (AC) or Amoxicillin-clavulanate 1g/152 mg tid. and Ciprofloxacin 500 mg bid. (AC+C) orally for 7 days, to be taken in case of CIF. Only the first episode of CIF of each patient will be included in the analysis. The main evaluation criterion will be clinical success, defined as apyrexia 4 days after the first antibiotic dose, without modification of antibiotic treatment. The main secondary evaluation criteria (recorded at Day 14) will be fever recurrence, hospital admission, modification of antibiotic treatment, treatment with a beta-lactamine antibiotic efficient against P. aeruginosa, duration of antibiotic treatment, bacteraemia, inefficiency of the study treatment against the identified bacteria, and adverse events of FQ.

Official title: Efficacy of an Empirical Treatment With Amoxicillin-clavulanate (AC) Compared to the Combination Amoxicillin-clavulanate and Ciprofloxacin (AC+C) in the Outpatient Care of Chemotherapy-induced Fever in Adult Haematology Patients. AC-CIF Protocol

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1526

Start Date

2026-03

Completion Date

2028-09

Last Updated

2026-03-19

Healthy Volunteers

No

Conditions

Interventions

DRUG

amoxicillin-clavulanate

Oral treatment, for 7 days duration, with amoxicillin-clavulanate 1g/125 mg tid. (AC)

DRUG

Amoxicillin-clavulanate ciprofloxacin

Oral treatment, for 7 days duration, with amoxicillin-clavulanate 1g/125 mg tid. and ciprofloxacin 500 mg bid. (AC+C)

Locations (16)

CH Jacques Coeur

Bourges, France

CH de BRIVE LA GAILLARDE

Brive-la-Gaillarde, France

CHU Caen-Normandie

Caen, France

CH de Versailles

Le Chesnay, France

CHU d'ORLEANS

Orléans, France

Hopital de La Pitie Salpetriere

Paris, France

Hopital Necker Enfants Malade

Paris, France

Hopital Saint Louis

Paris, France

CH de Perigueux

Périgueux, France

CH Poissy Saint-Germain-en-Laye

Poissy, France

Institut Curie

Saint-Cloud, France

CH de SAINT NAZAIRE

Saint-Nazaire, France

CHU de SAINT-ETIENNE

Saint-Priest-en-Jarez, France

CH de SAUMUR

Saumur, France

CH de Valence

Valence, France

Groupe Hospitalier Haute Saône Vesoul

Vesoul, France