amoxicillin-clavulanate
DrugOral treatment, for 7 days duration, with amoxicillin-clavulanate 1g/125 mg tid. (AC)
NCT Number: NCT07483736
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
CH Jacques Coeur, Bourges, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral treatment, for 7 days duration, with amoxicillin-clavulanate 1g/125 mg tid. (AC)
Oral treatment, for 7 days duration, with amoxicillin-clavulanate 1g/125 mg tid. and ciprofloxacin 500 mg bid. (AC+C)
Time frame: 4 days
Clinical success, defined as apyrexia measured 4 days after the first antibiotic dose, without modification of antibiotic treatment
Time frame: Day 1 to Day 14; Hour 48; Day 4; Day 14
Time frame: (Hour 48; Day 4; Day 14; Day 30)
Time frame: (Hour 48; Day 14; Day 30)
Time frame: (Day 14; Day 30)
Time frame: (Day 14; Day 30)
Time frame: (Hour 48; Day 4; Day 14)
Time frame: Day 1 to Day 7
Time frame: (Hour 48; Day 4; Day 14)
Time frame: (Day 14)
Time frame: (Day 14)
Time frame: (Day 14)
Time frame: (Day 14)
Time frame: (Day 14)
Time frame: Hour 48
Time frame: Day 14
Hospitalization, vital status, occurrence of the following events:
tendinous pain, joint pain, confusion, QT prolongation, cardiac rhythm disorder, allergy, C. difficile colitis
Time frame: Day 30
Contact information is provided by the study sponsor or research team.
Versailles Hospital
Other
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
Acronym: AC-CIF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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