Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
92
Countries
1
Sites
1
Pregnancy
Determine the antibiotic concentration in maternal blood and newborn blood (from the umbilical cord) and investigate the potential difference in antibiotic concentration between twin siblings.
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 5 Jan 2023 → ongoing
- Decision date (initial)
- 2024-12-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518564-12-00
- EudraCT number
- 2022-001956-40
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
Determine the antibiotic concentration in maternal blood and
newborn blood (from the umbilical cord) and investigate the potential
difference in antibiotic concentration between twin siblings.
Secondary objectives 3
- Evaluate maternal postoperative infection or sepsis and early-onset neonatal sepsis.
- Safety and tolerability of the antibiotics will be collected to define any adverse drug reaction (clinically observed, haematological or biochemical) that is reported by the clinical staff that is suspected as being caused by any of the study antibiotics.
- Substudy endpoints: Evaluate differences in antibiotic concentration between monochorionic and dichorionic twin pairs
Conditions and MedDRA coding
Pregnancy
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Women with twin pregnancies and delivery through c-section between 24- 42 gestational weeks
- Receiving one or more of the included antibiotic agents
- Able and willing to sign the consent
- Ages 18-55 years old
Exclusion criteria 2
- Any medical condition that, in the opinion of the Investigator or research team member, could potentially interfere with the study objectives
- Patients who are not willing to sign the consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pharmacokinetic: Differences in antibiotic concentration between twin pairs, Antibiotic cord/maternal ratio, The maternal antibiotic volume of distribution (Vd), clearance (Cl), Protein binding (PB), Placenta interstitial fluid concentration, Umbilical cord antibiotic concentration
Secondary endpoints 3
- Clinical descriptive endpoints: Maternal postoperative infection or sepsis, Early-onset neonatal sepsis.
- Safety endpoints: Safety and tolerability of the antibiotics will be collected to define any adverse drug reaction (clinically observed, haematological or biochemical) that is reported by the clinical staff that is suspected as being caused by any of the study antibiotics.
- Substudy endpoints: Differences in antibiotic concentration between monochorionic and dichorionic twin pairs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Kefzol 2 g – Trockensubstanz zur Infusionsbereitung
PRD4852200 · Product
- Active substance
- Cefazolin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DB04 — -
- Marketing authorisation
- 15.877
- MA holder
- ASTRO-PHARMA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dalacin C® Phosphat 600 mg/4 ml – Ampulle
PRD411322 · Product
- Active substance
- Clindamycin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01FF01 — CLINDAMYCIN
- Marketing authorisation
- 1-16060
- MA holder
- PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Piperacillin/Tazobactam Sandoz 4,0 g/0,5 g - Pulver zur Herstellung einer Infusionslösung
PRD892501 · Product
- Active substance
- Piperacillin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 4.5 g gram(s)
- Max total dose
- 4.5 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 1-27822
- MA holder
- SANDOZ GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Standacillin 2 g – Pulver zur Herstellung einer Injektions-/Infusionslösung
PRD743112 · Product
- Active substance
- Ampicillin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 4 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA01 — AMPICILLIN
- Marketing authorisation
- 17201
- MA holder
- SANDOZ GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Clinical Pharmacology
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Clinical Pharmacology
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 92 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2023-01-05 | 2023-02-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518564-12-00_redacted | 1.8 |
| Protocol (for publication) | D1_Protocol EUCT 2024-518564-12-00 | 1.7 |
| Recruitment arrangements (for publication) | Placeholder | 1 |
| Recruitment arrangements (for publication) | Placeholder_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_pregnantPK_normalgroup | 1.10 |
| Subject information and informed consent form (for publication) | L1_ICF_pregnantPK_normalgroup-redacted | 1.10 |
| Subject information and informed consent form (for publication) | L1_ICF_pregnantPK_substudy | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF_pregnantPK_substudy_redacted | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dalacin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Kefzol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Piperacillin-Taz | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Standacillin | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-518564-12-00-SM01_DE_clean | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-518564-12-00-SM01_DE_markup | 1 |
| Synopsis of the protocol (for publication) | D1_Protokollsynopse_PK_Pregnancy_DE | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-22 | Austria | Acceptable 2024-12-06
|
2024-12-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-30 | Austria | Acceptable 2025-10-01
|
2025-10-06 |