Clinical trial • Phase IV • Other

Benzylpenicillin sodium for Group G Streptococcal colonization | Group C Streptococcal colonization

Phase IV trial of Benzylpenicillin sodium for Group G Streptococcal colonization | Group C Streptococcal colonization. Randomised. 696 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Group G Streptococcal colonization | Group C Streptococcal colonization
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
26-10-2024
First CTIS Authorization Date
26-11-2024

Trial design

Randomised Phase IV trial across 3 sites in Finland.

Randomised
Yes
Target Sample Size
696
Trial Duration For Participant
90

Eligibility

Recruits 696 Pregnant women are selected as the study population (isVulnerablePopulationSelected = true). Subject information and informed consent form documents are listed in the trial documents, but no explicit description of consent/assent handling is provided in the available data..

Vulnerable Population
Pregnant women are selected as the study population (isVulnerablePopulationSelected = true). Subject information and informed consent form documents are listed in the trial documents, but no explicit description of consent/assent handling is provided in the available data.

Inclusion criteria

  • {"criterion_text":"- 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

  • {"criterion_text":"- 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 endpoints

  • {"endpoint_text":"- A postpartum infection of the mother requiring antibiotic treatment up to 3 months after delivery","definition_or_measurement_approach":"Measured as occurrence of a postpartum maternal infection that requires antibiotic treatment within 3 months after delivery."}

Secondary endpoints

  • {"endpoint_text":"- 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)","definition_or_measurement_approach":"Measured by documented positive maternal blood culture, recorded mode of delivery, documentation of whether a blood culture was taken from the newborn, recorded antibiotic treatment of the newborn, recorded transfer to NICU, and recorded length of hospital stay (days) for mother and newborn."}

Recruitment

Planned Sample Size
696
Recruitment Window Months
38
Consent Approach
Subject information and informed consent form documents are listed among trial documents. Participants are pregnant adult women and therefore consent is provided by the participant. No explicit details on assent, age-specific documents or languages are provided in the available data.

Geography

Total Number Of Sites
3
Total Number Of Participants
696

Finland

Earliest CTIS Part Ii Submission Date
07-11-2024
Latest Decision Or Authorization Date
26-11-2024
Processing Time Days
19
Number Of Sites
3
Number Of Participants
696

Sites

Site Name
Tampere University Hospital
Department Name
Dept of OB/GYN
Contact Person Name
Jukka Uotila
Contact Person Email
jukka.uotila@fimnet.fi
Site Name
Etela-Pohjanmaan Sairaanhoitopiiri
Department Name
Department of OB&GYN
Contact Person Name
Tiina-Liisa Erkinheimo
Site Name
University Of Oulu
Department Name
Department of OB&GYN
Contact Person Name
Liisa Laatio
Contact Person Email
liisa.laatio@oulu.fi

Sponsor

Primary sponsor

Full Name
University Of Oulu
Organisation Type
Educational Institution
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
Benzylpenicillin Panpharma 3 g injektio-/infuusiokuiva-aine, liuosta varten
Active Substance
Benzylpenicillin sodium
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation number present)
Maximum Dose
30 g per day
Investigational Product Name
Clindamycin Fresenius Kabi 150 mg/ml injektioneste, liuos / infuusiokonsentraatti, liuosta varten
Active Substance
Clindamycin phosphate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation number present)
Maximum Dose
2700 mg per day

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