Amoxicillin-clavulanate alone or in combination with Ciprofloxacin in Low-Risk Febrile Neutropenic adult Patients: A Prospective, Double-blind, Randomized, Non-InferiorityMulticenter, Phase III Clinical Trial

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10076734Term: Chemotherapy induced neutropeniaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003159-13-FR
• Lead Sponsor: CHU DE POITIERS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-03
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

- Patient = 18 years old.
- Treated for a solid cancer or a hematological malignancy.
- Presented with low-risk febrile neutropenia (low risk is defined by MASCC score = 21) due to chemotherapy with an expected duration of neutropenia = 7 days.
- Neutropenia is defined by an absolute neutrophil count =500/mm3.
- Fever is defined by temperature = 38.3° or = 38° twice during a 1-hour interval.
- Patient affiliated to an appropriate health insurance.
- Signing informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Hypersensitivity to the active substances: amoxicillin-clavulanic, ciprofloxacin, penicillins, to other quinolones or to one of the excipient
- History of severe immediate hypersensitivity reaction to another beta-lactam
- History of jaunditis/hepatic impairment related to amoxicillin/clavulanic
-Concomitant administration of ciprofloxacin and tizanidine.
- Clinical signs of focal infection including history of untreated dental abscess.
- Signs of sepsis or organ failure.
- Severe immune deficiency other than the current cancer, except controlled-HIV infection.
- Gastrointestinal symptoms requiring intravenous treatment (mucositis, vomiting,...).
- Known aminotransferase serum levels > 5 x normal values
- Know renal insufficiency defined as creatinine clearance of < 30 mL/min (MDRD).
- Antibiotherapy within 24h before enrollment. Prophylactic use of amoxicillin is an exclusion criterium whereas prophylactic use of trimethoprim–sulfamethoxazole (cotrimoxazole) and penicillin G (Oracilline®) are not and will be considered in the analysis.
- History of infection or colonization due to bacteria resistant to experimental drugs in the previous year
- Can be enrolled in the study only once.
- Patients not benefiting from a Social Security scheme or not benefiting from it through a third party.
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies.
- Pregnant or breastfeeding women, women at age to procreate and not using effective contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified