Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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
amoxicillin-clavulanate
Oral treatment, for 7 days duration, with amoxicillin-clavulanate 1g/125 mg tid. (AC)
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