Benefits of early discontinuation of antibiotic therapy versus standard management in elderly patients hospitalized for viral infection: a multicenter, open-label, cluster-randomized controlled study

2024-515695-13-00 Protocol PI2023_843_0153 Phase III and Phase IV (Integrated) Ongoing, recruiting

Start 2 Feb 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 7 sites · Protocol PI2023_843_0153

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)
Status Ongoing, recruiting
Participants planned 256
Countries 1
Sites 7

elderly patients hospitalized for viral infections

To show that early cessation of antibiotics in viral pneumonia (presumed or confirmed) reduces antibiotic consumption at one month.

Key facts

Sponsor
Centre Hospitalier Universitaire Amiens Picardie
Participant type
Patients
Age range
65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration
2 Feb 2026 → ongoing
Decision date (initial)
2025-02-14
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
DGHOS, PHRCIR 2021, GIRCI Nord-Ouest

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To show that early cessation of antibiotics in viral pneumonia (presumed or confirmed) reduces antibiotic consumption at one month.

Secondary objectives 4

  1. show that early cessation of antibiotics in the absence of microbiological confirmation : reduces the occurrence of side effects
  2. reduces the duration and complications of hospitalization
  3. does not modify mortality or autonomy at M1 and M3
  4. does not modify antibiotic consumption at M3

Conditions and MedDRA coding

elderly patients hospitalized for viral infections

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Standard group versus experimental group
This is a comparative study, conducted with 2 groups of centers: - Standard group: rapid analysis of respiratory samples + usual care - Experimental group: rapid analysis of respiratory samples + early discontinuation of antibiotics The choice of each group of centers, standard or experimental, is by drawing lots
 Randomised Controlled None

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Patient hospitalized for a lower respiratory infection defined as : o the presence of 2 of the following 4 signs : o hyperthermia >38°C, o hyperleukocytosis ≥12000 or ≤4000, o aspirations/purulent sputum, o rales on pulmonary auscultation indicating parenchymal involvement o associated with a pulmonary image (standard X-ray, CT or ultrasound).
  2. Microbiological diagnostic sample taken within 48 hours

Exclusion criteria 8

  1. Planned hospitalization < 48 h or transfer to another center within 7 days
  2. Patient in septic shock
  3. Febrile aplasia
  4. No diagnostic microbiological sample (>48h after admission)
  5. Moribund patient
  6. Death expected within a week
  7. Inhalation proven by endoscopy or eyewitness
  8. Purulent pleurisy, lung abscess, or other concomitant bacterial infection requiring antibiotic therapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Number of days without antibiotics at D30

Secondary endpoints 5

  1. Side effects of antibiotics: (collected in the eCRF at each occurrence) o Clostridial colitis, o venitis, o diarrhea, o nausea, o vomiting, o BMR germ colonization, o allergy, o other attributable effect: specify
  2. Other complications: o nosocomial infections, o complications of decubitus, o intra-hospital mortality from any cause, o confusion, o other complication attributable to hospitalization and the reason for hospitalization: specify
  3. Mortality at M1 and M3 or autonomy: ADL and IADL score at M1 and M3 (compared to those 15 days before hospitalization)
  4. Duration of hospitalization in acute care (in days)
  5. Number of days without antibiotics at M3

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Ceftriaxone

SUB07431MIG · Substance

Active substance
Ceftriaxone
Pharmaceutical form
POWDER FOR SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
1 g gram(s)
Max total dose
7 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin Sodium

SCP1153878 · ATC

Active substance
Piperacillin Sodium
Route of administration
IV INJECTION, IV INFUSION
Max daily dose
12 g gram(s)
Max total dose
84 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PYOSTACINE 500 mg, comprimé pelliculé

PRD581656 · Product

Active substance
Pristinamycin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
3 g gram(s)
Max total dose
21 g gram(s)
Max treatment duration
7 Month(s)
Authorisation status
Authorised
ATC code
J01FG01 — PRISTINAMYCIN
Marketing authorisation
34009 558 332-5 3
MA holder
SANOFI WINTHROP INDUSTRIE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Amoxicillin Sodium

SCP109545371 · ATC

Active substance
Amoxicillin Sodium
Route of administration
INJECTION
Max daily dose
3 g gram(s)
Max total dose
21 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01CR02 — AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Amiens Picardie

25 Total trials 11 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Centre Hospitalier Universitaire Amiens Picardie
Address
1 Rond Point Du Pr Christian Cabrol
City
Amiens Cedex 1
Postcode
80054
Country
France

Scientific contact point

Organisation
Centre Hospitalier Universitaire Amiens Picardie
Contact name
Coordinating Investigator

Public contact point

Organisation
Centre Hospitalier Universitaire Amiens Picardie
Contact name
Clinical project manager

Locations

1 EU/EEA country · 7 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 256 7
Rest of world — 0 —

Investigational sites

France

7 sites · Ongoing, recruiting
Centre Hospitalier Universitaire De Caen Normandie
Infectious and Tropical Diseases Department, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier De Tourcoing
Infectious Diseases Department, 155 Rue Du President Coty, Bp 40619, Tourcoing Cedex
Centre Hospitalier Universitaire Amiens Picardie
Infectious and Tropical Diseases Department, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Simone Veil De Beauvais
Geriatric Medicine Unit, 40 Avenue Leon Blum, 60000, Beauvais
Centre Hospitalier Universitaire De Lille
Day Hospital Service, Multidisciplinary assessment of falls in the elderly, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier General De Soissons
Internal Medicine, Infectious Diseases and Geriatrics Department, 46 Avenue Du General De Gaulle, 02200, Soissons
Centre Hospitalier Universitaire Rouen
Geriatric Internal Medicine Department, 147 Avenue Du Marechal Juin, 76230, Bois-Guillaume

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2026-02-02 2026-02-02

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D_Protocol_2024-515695-13-00 2.0
Protocol (for publication) D1_Protocol _2024-515695-13-00 1.1
Protocol (for publication) D1_Protocol _2024-515695-13-00 avec TC 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_SIS and ICF _adults 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF _adults avec TC 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF _curatelle 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF _curatelle 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF _curatelle - TC 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF _curatelle avec TC 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF _tutelle 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF _tutelle avec TC 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF adults 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF adults - TC 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF_tutelle 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_tutelle - TC 1.2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC _Ceftriaxone 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC _Piperacilline-Tazobactam 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC _Pristinamycine 1
Synopsis of the protocol (for publication) D1_ Protocol synopsis_2024-515695-13-00 2.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis_2024-515695-13-00 - TC 2.0

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-24 France Acceptable
2025-02-10
 2025-02-14
2 SUBSTANTIAL MODIFICATION SM-1 2026-01-29 France Acceptable
2026-02-20
 2026-03-11

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