Overview
Sponsor-declared trial summary
Participants are pregnant women found to carry Group G or C Streptococcus as part of their vaginal-rectal flora in the late pregnancy vaginal-rectal culture routinely taken for GBS screening
To evaluate the efficacy of intrapartum antibiotic profylaxis for the prevention of Group G/C infections of the mother and the newborn
Key facts
- Sponsor
- University Of Oulu
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 26 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519263-18-00
- EudraCT number
- 2020-002696-34
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis
To evaluate the efficacy of intrapartum antibiotic profylaxis for the prevention of Group G/C infections of the mother and the newborn
Secondary objectives 1
- To clarify the role of group G/C streptococcus as a causative pathogen in the infections of the mother and the newborn during labour and postpartum/neonatal period
Conditions and MedDRA coding
Participants are pregnant women found to carry Group G or C Streptococcus as part of their vaginal-rectal flora in the late pregnancy vaginal-rectal culture routinely taken for GBS screening
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10004038 | Bacterial infection due to streptococcus group C | 10021881 |
| 20.1 | LLT | 10004040 | Bacterial infection due to streptococcus group G | 10021881 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- All pregnant women who are shown by late pregnancy culture (taken at 35+0-38+0 gestational weeks) to carry group G or C Streptococcus in their vaginal-rectal flora are asked to participate
Exclusion criteria 1
- Exclusion criteria are as follows: The expectant mother carries both Group B Streptococcus (GBS) and group G/C Strptococcus; the expectant mother has had a urinary infection caused by Group B streptococcus at any time during her pregnancy or a previous child with GBS infection, as these women will routinely recieve antibiotic profylaxis;
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- A postpartum infection of the mother requiring antibiotic treatment up to 3 months after delivery
Secondary endpoints 1
- Positive blood culture of the mother, mode of delivery, need for blood culture from the newborn, antibiotic treatment of the newborn, transfer to NICU, days in the hospital for the mother and the newborn (lenght of stay after birth/delivery)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Benzylpenicillin Panpharma 3 g injektio-/infuusiokuiva-aine, liuosta varten
PRD2715127 · Product
- Active substance
- Benzylpenicillin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 30 g gram(s)
- Max total dose
- 210 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CE01 — BENZYLPENICILLIN
- Marketing authorisation
- 16595
- MA holder
- PANPHARMA
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Clindamycin Fresenius Kabi 150 mg/ml injektioneste, liuos / infuusiokonsentraatti, liuosta varten
PRD715223 · Product
- Active substance
- Clindamycin Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2700 mg milligram(s)
- Max total dose
- 18900 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01FF01 — CLINDAMYCIN
- Marketing authorisation
- 24305
- MA holder
- FRESENIUS KABI AB
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Oulu
- Sponsor organisation
- University Of Oulu
- Address
- P. O. Box 23
- City
- Oulu
- Postcode
- 90029
- Country
- Finland
Scientific contact point
- Organisation
- University Of Oulu
- Contact name
- Liisa Laatio
Public contact point
- Organisation
- University Of Oulu
- Contact name
- Liisa Laatio
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 696 | 3 |
| 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 |
|---|---|---|---|---|---|
| Finland | 2024-11-26 | 2024-11-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | POGSI - Tutkimussuunnitelma versio 1 | 1 |
| Recruitment arrangements (for publication) | Selvitys tutkittavan rekrytoinnista | 1 |
| Subject information and informed consent form (for publication) | POGSI - Tiedote tutkittavalle ja tutkittavan suostumusasiakirja | 2 |
| Subject information and informed consent form (for publication) | Tiedote tutkittavalle versio 2_ | 2 |
| Synopsis of the protocol (for publication) | Yhteenveto tutkimussuunnitelmasta | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-26 | Finland | Acceptable 2024-11-26
|
2024-11-26 |