Clinical trial • Phase III • Infectious Disease

VANCOMYCIN HYDROCHLORIDE for Infectious disease

Phase III trial of VANCOMYCIN HYDROCHLORIDE for Infectious disease. 150 participants.

Overview

Phase III trial across 1 site in Finland.

Recruits 150 paediatric patients.

Vulnerable Population: Children are a vulnerable population (isVulnerablePopulationSelected: true). Subject information and informed consent forms exist for guardians and age-specific ICFs: 'L1_SIS and ICF_Guardian', 'L1_SIS and ICF_under 12v', 'L1_SIS and ICF_12-14y', 'L1_SIS and ICF_15-16y' (including redacted versions). Consent is via guardian forms and age-specific information/ICF documents for different child age groups (under 12, 12-14, 15-16).

{"criterion_text":"- Iv-antibiotic treatment is necessary\n- Clinically stable\n- No need to stay in hospital\n- Pump or cassette can be changed at the hospital or at home\n- Care givers are able to contact hospital if needed\n- Clinical diagnose is not uncertain\n- No allergy for the used antibiotic\n- The continuous antibiotic infusion hasn’t been started yet or it has been initiated no more than 24 hours prior to study enrolment"}

{"criterion_text":"- The pump cannot be carried with the child\n- The child must stay at the hospital for monitoring or other reason\n- Unclear diagnose"}

{"endpoint_text":"- Duration of hospital stay / fever / antibiotic treatment","definition_or_measurement_approach":""}
{"endpoint_text":"- Readmission to hospital","definition_or_measurement_approach":""}
{"endpoint_text":"- Possible relapse (defined separately for each patient case)","definition_or_measurement_approach":"Defined separately for each patient case (as stated)"}

Planned Sample Size: 150
Recruitment Window Months: 58
Consent Approach: Informed consent obtained from guardians (guardian ICF available). Age-specific subject information and ICFs available for under 12, 12-14 years, and 15-16 years (documents listed: guardian and age-group ICFs, including redacted versions). Languages not specified in the provided data.

Investigational Product Name: Vancosan 500 mg, Infuusiokuiva-aine, liuosta varten
Active Substance: VANCOMYCIN HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised
Maximum Dose: 3 g (max daily dose)

Investigational Product Name: Cloxacillin Navamedic 2 g injektio-/infuusiokuiva-aine liuosta varten
Active Substance: CLOXACILLIN
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised
Maximum Dose: 12 g (max daily dose)

Investigational Product Name: Benzylpenicillin Fresenius Kabi 1,2 g (2 milj. IU) injektio-/infuusiokuiva-aine liuosta varten
Active Substance: BENZYLPENICILLIN SODIUM
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised
Maximum Dose: 20000000 IU (max daily dose)

Investigational Product Name: Piperacillin/Tazobactam Kalceks 2 g/0,25 g infuusiokuiva-aine, liuosta varten
Active Substance: PIPERACILLIN, TAZOBACTAM
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised
Maximum Dose: 12 g (max daily dose, combined piperacillin component units as provided)

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