Amoxicillin-clavulanate Alone or in Combination With Ciprofloxacin in Low-Risk Febrile Neutropenic Adult Patients: A Prospective, Double-blind, Randomized, Non-Inferiority Multicenter, Phase III Clinical Trial. (ACACIA)
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| ClinicalTrials.gov Identifier: NCT04698057 |
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Recruitment Status :
Not yet recruiting
First Posted : January 6, 2021
Last Update Posted : November 29, 2021
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Sponsor:
Poitiers University Hospital
Information provided by (Responsible Party):
Poitiers University Hospital
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Brief Summary:
In low risk neutropenic fever in cancer, standard of care is the association of amoxicillin clavulanate and ciprofloxacin. But in this population, the rate of fever related to infection is very low, leading to a overtreatment of the patients. The aim of this study is to validate a descalation of the antibiotherapy with safety concerns.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Febrile Neutropenia | Drug: Placebo Drug: Amoxicillin Clavulanate Drug: Ciprofloxacin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 460 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Amoxicillin-clavulanate Alone or in Combination With Ciprofloxacin in Low-Risk Febrile Neutropenic Adult Patients: A Prospective, Double-blind, Randomized, Non-Inferiority Multicenter, Phase III Clinical Trial. |
| Estimated Study Start Date : | March 1, 2022 |
| Estimated Primary Completion Date : | June 1, 2025 |
| Estimated Study Completion Date : | June 1, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cyclic neutropenia
MedlinePlus related topics:
Fever
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Amoxicillin clavulanate + ciprofloxacin
Treatment with amoxicillin-clavulanate 1g tib and ciprofloxacine 750mg bid for 5 days
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Drug: Amoxicillin Clavulanate
Will be administred to all patients Drug: Ciprofloxacin Will be administred to patients in the standard of care arm |
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Experimental: Amoxicillin clavulanate + Placebo
Treatment with amoxicillin-clavulanate 1g tib for 5 days
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Drug: Placebo
The aim of the study is to validate the desescalation of the treatment to stop ciprofloxacin prescription that may not impact the outcome of the patients but add toxicity and antibiotics selection. Placebo will be administred in the experimental arm Drug: Amoxicillin Clavulanate Will be administred to all patients |
Primary Outcome Measures :
- Success rate [ Time Frame: 7 days ]
The success rate is defined by the proportion of patients receiving the tested regimen:
- with resolution of fever ≤72h after the start of antibiotics (total duration of antibiotics expected : 5 days)
- AND without any modification of the antibiotic regimen (route, dosage, combination total duration of antibiotics expected : 5 days),
- AND without fever recurrence in 48h following the discontinuation of antibiotics (so end of the measure of the main outcome at day 7).
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| Ages Eligible for Study: | 18 Years to 110 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient ≥ 18 years old
- Treated for a solid cancer or a hematological malignancy
- Presented with low-risk* febrile neutropenia 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.
- Signing informed consent *Low risk is defined by MASCC score ≥ 21
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, severe diarrhea...).
- Known aminotransferase serum levels > 5 x normal values.
- Known 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 (either hormonal / mechanical : oral, injection, subcutaneous, implantable, intrauterine device, or surgical : tubal ligation, hysterectomy, total ovariectomy).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04698057
Contacts
| Contact: Mathieu Puyade, MD, PhD | +33 5 49 44 32 76 | mathieu.puyade@chu-poitiers.fr | |
| Contact: Corinne Lorrain | +33 5 49 44 39 30 | Corinne.LORRAIN@chu-poitiers.fr |
Sponsors and Collaborators
Poitiers University Hospital
| Responsible Party: | Poitiers University Hospital |
| ClinicalTrials.gov Identifier: | NCT04698057 |
| Other Study ID Numbers: |
ACACIA |
| First Posted: | January 6, 2021 Key Record Dates |
| Last Update Posted: | November 29, 2021 |
| Last Verified: | November 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Neutropenia Febrile Neutropenia Hyperthermia Fever Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Body Temperature Changes Heat Stress Disorders Wounds and Injuries Amoxicillin Ciprofloxacin |
Clavulanic Acid Clavulanic Acids Amoxicillin-Potassium Clavulanate Combination Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors beta-Lactamase Inhibitors |