Clinical trial • Phase IV • Respiratory

CIPROFLOXACIN HYDROCHLORIDE / CIPROFLOXACIN for Community-acquired pneumonia

Phase IV trial of CIPROFLOXACIN HYDROCHLORIDE / CIPROFLOXACIN for Community-acquired pneumonia.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Community-acquired pneumonia
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
13-11-2024

Trial design

Randomised, open-label, individualized antibiotic treatment duration based on clinical response (evaluated through connected devices) versus conventional predetermined antibiotic duration left to the physician's judgement; antibiotics are oral agents selected by the physician (list of possible antibiotics is provided in trial products), specific dose/schedule per arm not specified in ctis record.-controlled, adaptive Phase IV trial in France.

Randomised
Yes
Open Label
Yes
Comparator
Individualized antibiotic treatment duration based on clinical response (evaluated through connected devices) versus conventional predetermined antibiotic duration left to the physician's judgement; antibiotics are oral agents selected by the physician (list of possible antibiotics is provided in trial products), specific dose/schedule per arm not specified in CTIS record.
Adaptive
True (stopping antibiotic treatment is determined based on patient clinical response evaluated through connected devices versus a conventional predetermined duration)
Target Sample Size
500
Trial Duration For Participant
30

Eligibility

Recruits 500 Vulnerable populations are not selected. Patients under legal guardianship are excluded. Homeless patients are excluded. Inclusion requires "Has given written informed consent", indicating that adult participants must provide written informed consent. No assent procedures for minors are described (trial includes only participants aged 18 years or more)..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
Vulnerable populations are not selected. Patients under legal guardianship are excluded. Homeless patients are excluded. Inclusion requires "Has given written informed consent", indicating that adult participants must provide written informed consent. No assent procedures for minors are described (trial includes only participants aged 18 years or more).

Inclusion criteria

  • {"criterion_text":"- Patient aged 18 years or more\n- Presenting with suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria: Fever (temperature > 38°C), Dyspnea, Cough, Production of purulent sputum, Crackles,\tRadiological evidence of a new infiltrate (on chest X-ray or CT scan)\n- In need for antibiotic treatment targeting respiratory tract, according to the physician in charge\n- No other site of infection besides respiratory\n- With home internet access (WIFI)\n- Affiliated to health insurance\n- Is able to take oral treatment\n- Has given written informed consent"}

Exclusion criteria

  • {"criterion_text":"- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency)\n- Contraindications to the study antibiotics\n- Concomitant steroid treatment only for patients treated with fluoroquinolones antibiotics\n- Pre-existing aortic aneurysm or dissection, family history of aortic aneurysm or dissection, Marfan syndrome, Ehlers-Danlos syndrome, Takayasu arthritis, uncontrolled arterial hypertension, atherosclerosis only for patients treated with fluoroquinolones antibiotics\n- Pregnancy\n- Breastfeeding\n- Life expectancy < 1 month\n- Patient under legal guardianship\n- Homeless patient\n- Patient unable to use the connected devices\n- Patient enrolled in another interventional clinical trial\n- Hospitalization following consultation\n- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, immunosuppressive treatments or corticosteroids (prednisolone equivalent) > 10 mg/day, transplant, myeloma, lymphoma, known HIV and CD4<400/mm3, sickle-cell disease, Child-Pugh class C cirrhosis)\n- Suspected or confirmed legionellosis\n- Atrial fibrillation / constitutive tachycardia (usual heart rate > 100/min)\n- Baseline oxygen saturation < 90%\n- Home oxygen therapy\n- More than 24 hours of antibiotics prior to consultation\n- Any other infection necessitating concomitant antibiotic treatment"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of cure at Day 15 after the start of treatment","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Percentage of cure at Day 30","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of antibiotic treatment","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Frequency and severity of adverse events between the 2 study arms","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Patients' evolution of pneumonia symptoms and quality of life between the 2 study arms","definition_or_measurement_approach":""}
  • {"endpoint_text":"- A composite endpoint defined by the observation of one of the events characterizing the response to antibiotic treatment, among: clinical failure or; microbiological failure or; emergence of antibiotic resistance","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to clinical recovery (regardless of microbiological recovery or resistance failure)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Presence or absence of antimicrobial resistance at any point during follow-up","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Association between specific antibiotics and respiratory microbiome evolution","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Association between specific antibiotics and gut microbiome evolution","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of antimicrobial treatment","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
500
Recruitment Window Months
25
Consent Approach
Written informed consent is required (inclusion criterion: "Has given written informed consent"). A subject information and informed consent form document (L1_SIS-ICF) is present in the documents. Trial materials include French translations; primary language materials appear to be French. No assent procedures are described (participants must be ≥18 years).

Methods

  • Recruitment at participating community primary care/medical offices in France (patients presenting to listed general practice / medical office trial sites).

Geography

Total Number Of Sites
10
Total Number Of Participants
500

France

Earliest CTIS Part Ii Submission Date
05-11-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
8
Number Of Sites
10
Number Of Participants
500

Sites

Site Name
Cabinet médical IPSO Paris Richard Lenoir
Department Name
Medical Office
Contact Person Name
Thomas HIVET
Contact Person Email
thomas.hivet@ipsosante.fr
Site Name
Cabinet médical IPSO Paris Ourcq
Department Name
Medical Office
Contact Person Name
Angèle CHENG
Contact Person Email
angele.cheng@ipsosante.fr
Site Name
Cabinet Carré Notre-Dame
Department Name
Medical Office
Contact Person Name
Emma D'ANGLEJAN
Site Name
Ma Maison Médicale - Saint-Cloud
Department Name
Medical Office
Contact Person Name
Claire BOURGEOIS
Site Name
Ipso Sante
Department Name
Medical Office
Contact Person Name
Nicolas DE CHANAUD
Contact Person Email
nicolas.dechanaud@ipsosante.fr
Site Name
Cabinet médical IPSO Paris Italie
Department Name
Medical Office
Contact Person Name
Roxane LIARD
Contact Person Email
roxane.liard@ipsosante.fr
Site Name
Cabinet médical IPSO Paris Nation
Department Name
Medical Office
Contact Person Name
Inès DUMORTIER
Contact Person Email
ines.dumortier@ipsosante.fr
Site Name
Maison Médicale Chemin Vert
Department Name
Medical Office
Contact Person Name
Sophie SEANG
Contact Person Email
sophie.seang@aphp.fr
Site Name
Cabinet médical IPSO Lyon Brotteaux
Department Name
Medical Office
Contact Person Name
Laurine Lebas
Contact Person Email
Laurine.lebas@ipsosante.fr
Site Name
Maison de santé pluriprofessionnelle universitaire Jacques Prévert
Department Name
Medical Office
Contact Person Name
Mathilde FRANCOIS
Contact Person Email
dr.francois.m@gmail.com

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
CIPROFLOXACIN
Active Substance
CIPROFLOXACIN HYDROCHLORIDE / CIPROFLOXACIN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
2
Maximum Dose
1.5 g per day
Investigational Product Name
CLARITHROMYCIN
Active Substance
DEMECLOCYCLINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
2
Maximum Dose
1 g per day
Investigational Product Name
AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
Active Substance
AMOXICILLIN SODIUM, CLAVULANIC ACID
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
2
Maximum Dose
3 g per day
Investigational Product Name
LEVOFLOXACIN
Active Substance
OFLOXACIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
2
Maximum Dose
1 g per day
Investigational Product Name
MOXIFLOXACIN
Active Substance
MOXIFLOXACIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
2
Maximum Dose
400 mg per day
Investigational Product Name
PRISTINAMYCIN
Active Substance
PRISTINAMYCIN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
2
Maximum Dose
3 g per day
Investigational Product Name
AMPICILLIN
Active Substance
AMPICILLIN SODIUM
Modality
Small molecule
Routes Of Administration
Buccal
Route
Buccal
Authorisation Status
2
Maximum Dose
2 g per day
Investigational Product Name
OFLOXACIN
Active Substance
OFLOXACIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
2
Maximum Dose
800 mg per day
Investigational Product Name
AMOXICILLIN
Active Substance
AMOXICILLIN SODIUM
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
2
Maximum Dose
3 g per day
Investigational Product Name
AZITHROMYCIN
Active Substance
AZITHROMYCIN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
2
Maximum Dose
500 mg per day
Investigational Product Name
ERYTHROMYCIN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
2
Maximum Dose
3 g per day

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