Febrile NeutropeniaPhase 3ACACIANCT04698057
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.
A Phase 3 study testing Amoxicillin Clavulanate and Ciprofloxacin in people with Febrile Neutropenia, run by Poitiers University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- Amoxicillin Clavulanate and Ciprofloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
About this study
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.
- Conditions
- Febrile Neutropenia
- Being tested
- Placebo, Amoxicillin Clavulanate, Ciprofloxacin
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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
Amoxicillin ClavulanateDrug
Will be administred to all patients
CiprofloxacinDrug
Will be administred to patients in the standard of care arm
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin clavulanate + ciprofloxacin | Active comparator | Treatment with amoxicillin-clavulanate 1g tib and ciprofloxacine 750mg bid for 5 days Receives: Drug: Amoxicillin Clavulanate; Drug: Ciprofloxacin |
| Amoxicillin clavulanate + Placebo | Experimental | Treatment with amoxicillin-clavulanate 1g tib for 5 days Receives: Drug: Placebo; Drug: Amoxicillin Clavulanate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
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).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Mar 2022 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Why it stopped: No enrolment due to Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698057
- Sponsor's protocol ID
- ACACIA
- Acronym
- ACACIA
- Status last verified
- Mar 2022
- First submitted
- 4 Jan 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04698057
- Acronym / sponsor ID
- ACACIA / ACACIA
- Conditions
- Febrile Neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrolment due to Covid-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin clavulanate + ciprofloxacin | Active comparator | Drug: Amoxicillin Clavulanate, Drug: CiprofloxacinTreatment with amoxicillin-clavulanate 1g tib and ciprofloxacine 750mg bid for 5 days |
| Amoxicillin clavulanate + Placebo | Experimental | Drug: Placebo, Drug: Amoxicillin ClavulanateTreatment with amoxicillin-clavulanate 1g tib for 5 days |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe 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 + Placebo |
| Amoxicillin ClavulanateWill be administred to all patients | Drug | Amoxicillin clavulanate + Placebo, Amoxicillin clavulanate + ciprofloxacin |
| CiprofloxacinWill be administred to patients in the standard of care arm | Drug | Amoxicillin clavulanate + ciprofloxacin |
Primary outcome
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amoxicillin Clavulanate and Ciprofloxacin in people with Febrile Neutropenia, run by Poitiers University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.