Biomodulina T in pediatric septic shock. Exploratory study

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the effect and safety of Biomodulina T in combination with conventional therapy in the treatment of pediatric septic shock. Exploratory Study.

Secondary indentifying numbers:

GEC2020BMT026

Issuing authority of the secondary identifying numbers:

Centro Nacional de Biopreparados (BioCen)

Source(s) of monetary or material support:

Centro Nacional de Biopreparados (BioCen) Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Yoandra

Last name:

Acevedo Rodriguez

Medical Specialty :

First degree specialist Integral General Medicine and First degree in Intensive Therapy and Emergency (pediatric profile).

Affiliation:

"Jose Luis Miranda" Pediatric Hospital.

Postal address:

July 26th Avenue and 1st. Reparto Escambray, Santa Clara

City:

Villa Clara

Country:

Cuba

Zip Code:

50200

Telephone:

+53-42271745

Email address:

yoandraar@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/10/2020

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Septic shock

Health condition(s) code:

Shock, Septic

Sepsis

Shock

Pathologic Processes

Systemic Inflammatory Response Syndrome

Pediatrics

Intervention(s):

Group 1 (Experimental): Conventional treatment +Biomodulina T. The conventional treatment(treatment established in the “José Luis Miranda” Pediatic Intensive Care Unit (PICU) based on international consensus and guidelines applied to patients in septic shock) plus Biomodulina T ˂ 1 year ½ bb = 1.5 mg; ≥ 1 year 1 bb = 3 mg, on alternate days the first 14 days, and twice a week the following 14 days, for a total of 11 doses, parenteral route. During admission to the PICU, intravenous route (IV) will be used and, once the patient is discharged from the PICU, it will be used intramuscular route (IM). Group 2 (control): Conventional treatment.

Intervention code:

Immunologic Factors Injections

Injections, Intramuscular

Infusions, Parenteral

Administration, Intravenous

Intervention keyword:

Biomodulin T

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. 28-day mortality (Depending on the condition of the patient, alive or deceased). Measurement time: final evaluation (2 months).

Key secondary outcomes:

1. Organic dysfunction (Number of organs affected (1, 2, 3, more than 3)). Measurement time: in the initial evaluation (day 1). 2. New dysfunction or progression of the previous one (Occurrence (yes or no), Degree of dysfunction (From 0 to 33 points)). Measurement time: in daily evaluations during admission to the PICU. 3. Degree of dysfunction (It will measure through the PELOD questionnaire). Measurement time: in the evaluations during admission to the PICU (Days 1, 2, 5, 8, 12, 16 and 18). If the patient leaves the PICU before any of those days, it is not evaluated. 4. New acquired infection (Occurrence (yes or no), classification (nosocomial or community)). Measurement time: daily evaluations during admission to the PICU, evaluations during treatment with BMT outside the PICU, evaluation at hospital discharge, Final evaluation (2 months). 5. Occurrence of complications (yes or no), Measurement time: daily evaluations during admission to the PICU, Evaluations during treatment with BMT outside the PICU, Evaluation at hospital discharge, Final Evaluation (2 months). 6. PICU stay (days), Measurement time: final evaluation (2 months). 7. Hospital stay (days).Measurement time: final evaluation (2 months). 8 Re-entry within 28 days (Occurrence (yes or no), cause (infectious or non-infectious)). Measurement time: final evaluation (2 months). 9. Nutritional status (Body Mass Index). Measurement time: initial evaluation, evaluation at hospital discharge and final evaluation (2 months). 10. Thymic Area (size in mm2). Measurement time: initial and, final evaluation (2 months). 11. CD4 + count (expressed in cel / µL and in%.). Measurement time: initial and, final evaluation (2 months). 12. Quantification of Immunoglobulins (IgA, IgM, IgG). Measurement time: initial and, final evaluation (2 months). 13. Vital signs (Blood pressure, heart rate, respiratory rate, temperature, oxygen saturation). Measurement time: in evaluations during treatment with BMT, before each administration and 1 h after them. 14. Adverse events (Occurrence (yes or no), Type (describe), Location (local or systemic), Time of appearance (minutes or hours), Duration (hours, minutes or days), Previous knowledge (expected or unexpected), Intensity (mild, moderate or severe), Consequence (severe or not serious), Causal relationship (Very probable / certain, Probable, Possible, Unlikely, Not related, Not evaluable / not classifiable)). Measurement time: in evaluations during BMT treatment, and, in the final evaluation (2 months).

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

29 days

Maximum age:

8 years

Inclusion criteria:

1. Patients who meet the diagnostic criteria. 2. Patients aged ≥ 29 days and <9 years. 3. Patients whose parents or legal guardians give their consent to participate in the study in writing.

Exclusion criteria:

1. Patients in whom randomization is not possible within the first 24 hours of being diagnosed. 2. Patients with histories of severe allergic reactions and / or generalized severe eczema. 3. Patients with a diagnosis of tumor or autoimmune disease. 4. Patients with a previous diagnosis of primary immunodeficiency. 5. Patients with a solid organ or stem cell transplant.

Type of population:

Children

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

60

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yoandra

Last Name:

Acevedo Rodriguez

Specialty:

First degree specialist Integral General Medicine and First degree in Intensive Therapy and Emergency (pediatric profile).

Affiliation:

"Jose Luis Miranda" Pediatric Hospital.

Postal Address:

July 26th Avenue and 1st. Cast Escambray, Santa Clara

City:

Villa Clara

Country:

Cuba

Zip Code:

50200

Telephone:

+53-42271745

Email :

yoandraar@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mary

Middle Name:

Carmen

Last Name:

Reyes Zamora

Specialty:

Frist Degree Specialist in Immunology, Master in Clinical Trials

Affiliation:

Centro Nacional de Biopreparados (BioCen), Group of Clinical Trials.

Postal Address:

Carretera Beltran Km 1 ½

City:

Bejucal, Mayabeque

Country:

Cuba

Zip Code:

13050, Box 6048

Telephone:

+53-4706682201 -07, ext: 1145 and 1147

Email :

mcarmen.reyes@biocen.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

"Jose Luis Miranda" Pediatric Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

15/06/2020

Postal address of Ethic Committee :

July 26th Avenue and 1st. Cast Escambray, Santa Clara. Villa Clara, ZC: 50200. Cuba

Telephone:

+53-42271745

Email:

miranda@capiro.vcl.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

01/12/2022

Date of available results:

01/05/2023

Date of first publication:

01/11/2023

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000327

Date of Registration in Primary Registry:

03/08/2020

Record Verification Date:

2020/08/03

Next update date:

2021/08/03

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Biomodulina T in pediatric septic shock. Exploratory study

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