Clinical trial • Phase III • Other

Ceftriaxone for Preterm prelabor rupture of membranes (PPROM)

Phase III trial of Ceftriaxone for Preterm prelabor rupture of membranes (PPROM).

Overview

Trial Therapeutic Area
Other
Trial Disease
Preterm prelabor rupture of membranes (PPROM)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-01-2026
First CTIS Authorization Date
28-04-2026

Trial design

Randomised, test arm: ceftriaxone (powder for solution for injection) administered iv/sc/im; product data indicates up to 1 g per day, total up to 7 g over 7 days. both arms include azithromycin. comparator arm: amoxicillin (oral) plus azithromycin (oral). amoxicillin product data indicates up to 3 g per day, total up to 21 g over 7 days. azithromycin product data indicates up to 500 mg per day, total up to 1500 mg over 5 days.-controlled Phase III trial in France.

Randomised
Yes
Comparator
Test arm: Ceftriaxone (powder for solution for injection) administered IV/SC/IM; product data indicates up to 1 g per day, total up to 7 g over 7 days. Both arms include azithromycin. Comparator arm: Amoxicillin (oral) plus Azithromycin (oral). Amoxicillin product data indicates up to 3 g per day, total up to 21 g over 7 days. Azithromycin product data indicates up to 500 mg per day, total up to 1500 mg over 5 days.
Target Sample Size
1008
Trial Duration For Participant
730

Eligibility

Recruits 1008 Pregnant women are the target population and 'isVulnerablePopulationSelected' is true. Inclusion limited to adults (18 years or older) who are French speaking and affiliated to French social security. Informed consent must be signed by the participant. Exclusion criteria explicitly exclude persons with a mental state preventing understanding/consent, persons deprived of liberty by administrative or judicial order, and persons under guardianship or conservatorship. No assent process is described..

Vulnerable Population
Pregnant women are the target population and 'isVulnerablePopulationSelected' is true. Inclusion limited to adults (18 years or older) who are French speaking and affiliated to French social security. Informed consent must be signed by the participant. Exclusion criteria explicitly exclude persons with a mental state preventing understanding/consent, persons deprived of liberty by administrative or judicial order, and persons under guardianship or conservatorship. No assent process is described.

Inclusion criteria

  • {"criterion_text":"- PPROM between 22 + 0/7 – 33 + 6/7 weeks of gestation, as diagnosed by obstetric team The diagnosis of PPROM is based on the combination of: (1) a suggestive clinical history AND (2) a physical examination (with or without a speculum) confirming discharge OR a positive laboratory test\n- Eligible to the standard protocol of antibiotic prophylaxis for PPROM in inclusion centre\n- Singleton gestation\n- Foetus alive at the time of randomization\n- 18 years of age or older\n- French speaking\n- Affiliated to any French social security regime or equivalent system\n- Informed consent signed"}

Exclusion criteria

  • {"criterion_text":"- Clinically suspected intra-uterine infection at the time of PPROM diagnosis (defined by association of PPROM AND fever (≥ 38°) AND at least two of the following signs: fetal tachycardia > 160 beats/min for 10 minutes, uterine pain or spontaneous labor, purulent amniotic fluid at the cervical os)\n- Ongoing antibiotic treatment (≥ 24h) by amoxicillin, 3CG or a macrolide at the time of inclusion (other antibiotics are not cause for exclusion)\n- Major foetal abnormality\n- Maternal allergy or contra-indication to any antibiotic(s) used in the randomised trial protocol\n- Current participation in another interventional study involving a drug\n- A mental state that prevents understanding of the trial and the ability to give free and informed consent\n- Persons deprived of their liberty by administrative or judicial order\n- Persons under guardianship or conservatorship\n- Person who is a relative of the investigator whom enrolled them in the study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Composite outcome including foetal death and/or neonatal death AND/OR neonatal severe morbidity (defined by ≥ 1 of the following: mechanical ventilation 48hrs, severe bronchopulmonary dysplasia, severe intraventricular haemorrhage, white matter injury, neonatal early-onset sepsis, neonatal late-onset sepsis, necrotizing enterocolitis, retinopathy of prematurity).","definition_or_measurement_approach":"Composite outcome combining fetal death and/or neonatal death and/or neonatal severe morbidity. Neonatal severe morbidity defined as presence of ≥1 of: mechanical ventilation ≥48 hrs, severe bronchopulmonary dysplasia, severe intraventricular haemorrhage, white matter injury, neonatal early-onset sepsis, neonatal late-onset sepsis, necrotizing enterocolitis, retinopathy of prematurity."}

Secondary endpoints

  • {"endpoint_text":"- Pregnancy duration","definition_or_measurement_approach":"Measured as duration (length) of pregnancy; no further measurement detail provided in the record."}
  • {"endpoint_text":"- Maternal infectious morbidity","definition_or_measurement_approach":"Maternal infectious morbidity: endpoint name provided but no additional measurement definition in the record."}
  • {"endpoint_text":"- Neonatal mild or moderate morbidity: 1. Prevalence of maternal or neonatal colonization/infection with ESBL- or 3rd generation cephalosporin-resistant- enterobacteria ; 2. Psycho-motor development at the age of 2 years by parental auto-questionnaire","definition_or_measurement_approach":"Neonatal mild/moderate morbidity includes (1) prevalence of colonization/infection with ESBL- or 3rd generation cephalosporin-resistant enterobacteria; (2) psychomotor development at 2 years assessed by parental self-questionnaire."}

Recruitment

Planned Sample Size
1008
Recruitment Window Months
64
Consent Approach
Informed consent must be signed by the participant. Participants must be 18 years or older and French speaking. Subject information and informed consent form documents are listed (L1_NIFC_Majeur and L1_NIFC_Autorite Parentale), but the record specifies adult consent only; no assent process described. Languages explicitly required: French.

Geography

Total Number Of Sites
16
Total Number Of Participants
1008

France

Earliest CTIS Part Ii Submission Date
15-04-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
13
Number Of Sites
16
Number Of Participants
1008

Sites

Site Name
Hôpital Universitaire Necker Enfants Malades - AP-HP
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Marine DRIESSEN
Principal Investigator Email
marine.driessen@aphp.fr
Contact Person Name
Marine DRIESSEN
Contact Person Email
marine.driessen@aphp.fr
Site Name
Robert Debre University Hospital
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Thomas SCHMITZ
Principal Investigator Email
thomas.schmitz@aphp.fr
Contact Person Name
Thomas SCHMITZ
Contact Person Email
thomas.schmitz@aphp.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Justine HUET
Principal Investigator Email
huet-j@chu-caen.fr
Contact Person Name
Justine HUET
Contact Person Email
huet-j@chu-caen.fr
Site Name
Trousseau Hospital
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Jeanne SIBIUDE
Principal Investigator Email
jeanne.sibiude@aphp.fr
Contact Person Name
Jeanne SIBIUDE
Contact Person Email
jeanne.sibiude@aphp.fr
Site Name
Hopital Antoine-Beclere
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Maelig ABGRAL
Principal Investigator Email
maelig.abgral@aphp.fr
Contact Person Name
Maelig ABGRAL
Contact Person Email
maelig.abgral@aphp.fr
Site Name
CHRU De Nancy
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Olivier MOREL
Principal Investigator Email
o.morel@chru-nancy.fr
Contact Person Name
Olivier MOREL
Contact Person Email
o.morel@chru-nancy.fr
Site Name
CHU Saint Etienne Hôpital Nord
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Tiphaine BARJAT
Principal Investigator Email
tiphaine.barjat@chu-st-etienne.fr
Contact Person Name
Tiphaine BARJAT
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Loïc SENTILHES
Principal Investigator Email
loic.sentilhes@aphp.fr
Contact Person Name
Loïc SENTILHES
Contact Person Email
loic.sentilhes@aphp.fr
Site Name
Hopital Louis Mourier
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Olivier PICONE
Principal Investigator Email
olivier.picone@aphp.fr
Contact Person Name
Olivier PICONE
Contact Person Email
olivier.picone@aphp.fr
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Elie AZRIA
Principal Investigator Email
eazria@ghpsj.fr
Contact Person Name
Elie AZRIA
Contact Person Email
eazria@ghpsj.fr
Site Name
Assistance Publique Hopitaux De Paris (Bondy)
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Amélie BENBARA
Principal Investigator Email
amelie.benbara@aphp.fr
Contact Person Name
Amélie BENBARA
Contact Person Email
amelie.benbara@aphp.fr
Site Name
Hôpitaux Universitaires Paris Centre-Hôpital Cochin
Department Name
Gynécologie Obstétrique
Principal Investigator Name
François GOFFINET
Principal Investigator Email
francois.goffinet@aphp.fr
Contact Person Name
François GOFFINET
Contact Person Email
francois.goffinet@aphp.fr
Site Name
Hôpital Bicêtre -APHP
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Dominique LUTON
Principal Investigator Email
dominique.luton@aphp.fr
Contact Person Name
Dominique LUTON
Contact Person Email
dominique.luton@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Paul GUERBY
Principal Investigator Email
guerby.p@chu-toulouse.fr
Contact Person Name
Paul GUERBY
Contact Person Email
guerby.p@chu-toulouse.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Mary PONTVIANNE
Principal Investigator Email
mary.pontvianne@chru-strasbourg.fr
Contact Person Name
Mary PONTVIANNE
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Gynécologie Obstétrique
Principal Investigator Name
Maela LE LOUS
Principal Investigator Email
maela.le.lous@chu-rennes.fr
Contact Person Name
Maela LE LOUS
Contact Person Email
maela.le.lous@chu-rennes.fr

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
CEFTRIAXONE
Active Substance
Ceftriaxone
Modality
Small molecule
Routes Of Administration
INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
Route
Intravenous/Subcutaneous/Intramuscular
Dose Levels
maxDailyDoseAmount: 1 g; maxTotalDoseAmount: 7 g; maxTreatmentPeriod: 7 days
Frequency
Up to 1 g per day
Maximum Dose
1 g per day, total 7 g
Investigational Product Name
AMOXICILLIN
Active Substance
Amoxicillin
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Dose Levels
maxDailyDoseAmount: 3 g; maxTotalDoseAmount: 21 g; maxTreatmentPeriod: 7 days
Frequency
Up to 3 g per day
Maximum Dose
3 g per day, total 21 g
Investigational Product Name
AZITHROMYCIN
Active Substance
Azithromycin
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Dose Levels
maxDailyDoseAmount: 500 mg; maxTotalDoseAmount: 1500 mg; maxTreatmentPeriod: 5 days
Frequency
Up to 500 mg per day
Maximum Dose
500 mg per day, total 1500 mg
Combination Treatment
Yes

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