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Clinical Trial NCT07483736 (AC-CIF) for C15.378 is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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) Phase 3 1,526 Randomized
Clinical Trial NCT07483736 (AC-CIF) is designed to study Prevention for C15.378. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 March 2026 until the study accrues 1,526 participants. Led by Versailles Hospital, this study is expected to complete by 1 September 2028. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
Brief 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 advers...Show More
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
Conditions
C15.378Other Study IDs
- AC-CIF
- P23/12 - AC-CIF
- 2025-520995-24-00 (EU Study (CTIS) Number)
NCT ID Number
Start Date (Actual)
2026-03
Last Update Posted
2026-03-19
Completion Date (Estimated)
2028-09
Enrollment (Estimated)
1,526
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
Febrile neutropenia
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentalamoxicillin-clavulanate [AC] Oral treatment, for 7 days duration, with amoxicillin-clavulanate 1g/125 mg tid. (AC) | Amoxicillin-clavulanate Oral treatment, for 7 days duration, with amoxicillin-clavulanate 1g/125 mg tid. (AC) |
Active Comparatoramoxicillin-clavulanate and ciprofloxacin [AC + C] Oral treatment, for 7 days duration, with amoxicillin-clavulanate 1g/125 mg tid. and ciprofloxacin 500 mg bid. (AC+C) | Amoxicillin-clavulanate ciprofloxacin Oral treatment, for 7 days duration, with amoxicillin-clavulanate 1g/125 mg tid. and ciprofloxacin 500 mg bid. (AC+C) |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Apyrexia at day 4 | Clinical success, defined as apyrexia measured 4 days after the first antibiotic dose, without modification of antibiotic treatment | 4 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Fever recurrence before Day 14 | Day 1 to Day 14; Hour 48; Day 4; Day 14 | |
Hospitalization for treatment failure (Hour 48; Day 4; Day 14; Day 30) | (Hour 48; Day 4; Day 14; Day 30) | |
Hospitalization in intensive care unit for treatment failure (Hour 48; Day 14; Day 30) | (Hour 48; Day 14; Day 30) | |
Death (Day 14; Day 30) | (Day 14; Day 30) | |
Death due to infection (Day 14; Day 30) | (Day 14; Day 30) | |
Adequacy of empirical antibiotic treatment to the treatment prescribed at randomization (Hour 48; Day 4; Day 14) | (Hour 48; Day 4; Day 14) | |
Treatment compliance (treatment compliance surveillance form Day1 to Day 7) | Day 1 to Day 7 | |
Any modification in antibiotic treatment (Hour 48; Day 4; Day 14) | (Hour 48; Day 4; Day 14) | |
Treatment with a beta-lactam antibiotic with efficacy against P. aeruginosa (Day 14) | (Day 14) | |
Antibiotic duration (Day 14) | (Day 14) | |
Bacteraemia (in the subgroup of secondarily hospitalized patients) (Day 14) | (Day 14) | |
Empirical antibiotic treatment inefficient against identified bacteria (in the subgroup of secondarily hospitalized patients) (Day 14) | (Day 14) | |
Pseudomonas aeruginosa bacteraemia (Day 14) | (Day 14) | |
Evaluation at H48 by phone call (hospitalization, vital status) | Hour 48 | |
Evaluation at Day 14 by phone call, review of medical charts and retrospective collection of biological and microbiological data | Hospitalization, vital status, occurrence of the following events:
tendinous pain, joint pain, confusion, QT prolongation, cardiac rhythm disorder, allergy, C. difficile colitis | Day 14 |
Evaluation at Day 30 by phone call (hospitalization, vital status) | Day 30 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Adult patients (≥ 18 years) with one of the following haematological disorders (in whom chemotherapy regimens are expected to provoke neutropenia lasting <7 days) (1) lymphoma of all histological types treated with the goal of remission; (2) myelodysplasia treated with azacytidine; (3) acute myeloblastic leukaemia, treated with a non-intensive scheme (azacytidine, azacytidine+venetoclax, other oral treatment against molecular targets)
- Written informed consent
- Patient able to understand all information related to the study and able to follow the protocol procedures (phone call and completion of the patient follow-up form (electronic or paper))
- Affiliated to or beneficiary of the welfare care
1. Patient under legal protection 2. Patient deprived of liberty by judicial or administrative decision 3. Patient who is the investigator, any member of the study team, or a relative directly involved in the trial, including assistant physicians, pharmacists, study coordinators, etc… 4. Participation in another interventional clinical trial 5. Impossible collection of informed consent (including non-francophone patient, or cognitive disorders) 6. Body mass index (BMI) > 30 7. Basal neutrophils count < 1000/mm3 (on the latest available blood test performed < 1 month before inclusion) 8. Aminotransferase serum levels > 5 X normal values (on the latest available blood test performed < 1 month before inclusion) 9. Creatinine clearance < 30 mL/min (on the latest available blood test performed < 1 month before inclusion) 10. Previous treatment with CAR-T cells 11. Previous allogeneic or autogeneic bone-marrow transplantation 12. Chronic obstructive pulmonary disease (COPD) 13. Previous invasive fungal infection 14. Allergy to one of the study medications 15. Contraindication to fluoroquinolones:
- hypersensitivity to ciprofloxacin, to other quinolones, or to any of the following excipients (microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, titanium dioxide),
- treatment with tizanidine,
- previous hypersensitivity to any quinolone,
- previous tendonitis attributed to any fluoroquinolone,
- epilepsy 16. Contraindication to amoxicillin-clavulanate 17. QT prolongation (defined as a QT interval > 0.45 seconds for males and > 0.47 seconds for females) 18. Antibiotic prophylaxis (with the exception of the combination sulfamethoxazole and trimethoprim) 19. Pregnant or breastfeeding women, 20. Women not using contraception 21. Patient treated with anti-psychotic drug
Versailles HospitalStudy Responsible Party
Clara FLATEAU, Principal Investigator, Principal Investigator, Poissy-Saint Germain Hospital
Study Central Contact
Contact: Mélody FORT, +33139239776, [email protected]
16 Study Locations in 1 Countries
CH Jacques Coeur, Bourges, France
Dr BOURREAU, Contact, +33248487294, [email protected]
CH de BRIVE LA GAILLARDE, Brive-la-Gaillarde, France
Dr VILLESUZANE, Contact, +3355592651, [email protected]
CHU Caen-Normandie, Caen, France
Dr DELAPIERRE, Contact, +33231272124, [email protected]
CH de Versailles, Le Chesnay, France
Pr ROUSSELOT, Contact, +33139638909, [email protected]
CHU d'ORLEANS, Orléans, France
Dr OCHMANN, Contact, +33238514210, [email protected]
Hopital de La Pitie Salpetriere, Paris, France
Dr BOUSSEN, Contact, +33142162834, [email protected]
Hopital Necker Enfants Malade, Paris, France
Dr SUAREZ, Contact, +33144495368, [email protected]
Hopital Saint Louis, Paris, France
Dr RAFFOUX, Contact, +33142499649, [email protected]
CH de Perigueux, Périgueux, France
Dr CALMETTES, Contact, +33553452585, [email protected]
CH Poissy Saint-Germain-en-Laye, Poissy, France
Dr FLATEAU, Contact, +33139274645, [email protected]
Institut Curie, Saint-Cloud, France
DR ELLOUZ, Contact, +33147111680, [email protected]
CH de SAINT NAZAIRE, Saint-Nazaire, France
Dr LESTANG, Contact, +33272278000, [email protected]
CHU de SAINT-ETIENNE, Saint-Priest-en-Jarez, France
Dr CORNILLON, Contact, +33477822856, [email protected]
CH de SAUMUR, Saumur, France
Dr TRUCHAN, Contact, +33241533544, [email protected]
CH de Valence, Valence, France
Dr ROBERT, Contact, +33475755769, [email protected]
Groupe Hospitalier Haute Saône Vesoul, Vesoul, France
Dr FAURE, Contact, +3384966579, [email protected]