DENIS Study

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:

Recombinant streptokinase in the treatment of complex complicated parapneumonic pleural effusion in pediatrics

Secondary indentifying numbers:

IG/CIGB-SK/DP/1701

Issuing authority of the secondary identifying numbers:

Provincial Pediatric Hospital "Dr. Eduardo Agramonte Piña ", Camaguey.

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, CUBA.

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)

Authorization date :

14/01/2020

Reference number:

37.001.19.BF4

Principal investigator

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

First name:

Yanet

Midle name:

de los Angeles

Last name:

Loret de Mola Bueno

Medical Specialty :

Doctor in Medical Sciences; 2nd degree specialist in Intensive Care and Emergency (Pediatric Profile).

Affiliation:

Provincial Pediatric Hospital "Dr. Eduardo Agramonte Pinna"

Postal address:

Dolores Betancourt No 2 entre Domingo Puentes y Carretera de Santa Cruz

City:

Camaguey

País:

Cuba

Zip Code:

10700

Telephone:

+53-32282014

Email address:

loret.cmw@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

Research ethics committees:

Provincial Pediatric Hospital "Dr. Eduardo Agramonte Piña ", December 19, 2017.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

17/09/2018

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:

Complicated parapneumonic pleural effusion

Health condition(s) code:

Pleural Effusion

Pleural Diseases

Respiratory Tract Diseases

Intervention(s):

Group I (Experimental): Intravenous antibiotic therapy (according to unit protocol, pleural puncture and placement of chest drainage under local anesthesia and sedation, and assisted video-assisted thoracoscopy in cases that require it) + thrombolytic therapy with Heberkinasa (recombinant streptokinase, a daily intrapleural administration of 200 000 IU of rSK for 3-5 days). Group II (Control): Intravenous antibiotic therapy (according to unit protocol, pleural puncture and placement of chest drainage under local anesthesia and sedation, and assisted video-assisted thoracoscopy in cases that require it).

Intervention code:

Streptokinase

Thrombolytic Therapy

Antibiotic Prophylaxis

Punctures

Drainage

Thoracoscopy

Thoracic Surgery, Video-Assisted

Administration, Intravenous

Intervention keyword:

Intrapleural administration

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) Need for surgical treatment (video-assisted thoracoscopy surgery – VATS, thoracotomy with decortication), (Yes, No) due to failure of conventional or experimental therapy (SKr). 2) Hospital stay, given by the time (in days) from the diagnosis of complex complicated parapneumonic pleural effusion (CCPPE)/empyema to hospital discharge (patients were transferred to another ward upon leaving intensive care).

Key secondary outcomes:

1) Resolution of the pleural effusion (in days) verified by chest x-ray in the anteroposterior position and chest ultrasound. Measurement time: daily until the spill is resolved. 2) Stay in intensive care: given by the time (in days) from the diagnosis of the condition under study until discharge (transfer) from intensive care. Measurement time: daily until discharge from intensive care. 3) Time of evolution (in days) of the complications accompanying CCPPE and empyema identified before the inclusion of the patient in the clinical trial. Measurement time: daily until the cessation of pre-inclusion complications. 4) Time of oxygen therapy/ventilator support requirement (in days). 5) Need (Yes, No) and time (in days) of oxygen therapy / ventilatory support requirement after the intervention in patients not ventilated at the time of inclusion in the study. If included in the trial with any ventilatory support, the time required (days) will be measured. Measurement time: daily during admission to intensive care. 6) Time (in days) to remove the chest drain from its insertion, due to resolution of the pleural effusion proven by chest x-ray and ultrasound. Measurement time: daily until drain extraction. 7) Post-fibrinolysis and post-VATS pleural drainage time (in days) from the end of fibronolytic or surgical therapy. Measurement time: daily until drain extraction. 8) Mortality (Yes, No). Measurement time: during the hospital stay. 9) Safety measured through the appearance of clinical adverse events (Occurrence of AE (Yes, No). Description of the AE (name of the event). Intensity of the AE (mild, moderate, severe). Causality (Unrelated, Doubtful, Possible, Probable, Definitive). Outcome (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event).

Selection criterias

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

Gender:

Male/Female

Minimum age:

1 year

Maximum age:

18 years

Inclusion criteria:

1) Patients of any sex, with ages between 1 and 18 years. 2) Patients diagnosed with complicated complicated parapneumonic pleural effusion, who meet any of these clinical criteria: a) Complex pleural effusion, with septa, partitions or particles in suspension in the chest ultrasound that persists after 12 hours of placement of the pleural drainage. b) Fibrin finding in the chest drainage placement procedure. c) Appearance of septa, septa or fibrin within 10 days after drainage is placed. 3) Voluntariness of the parents or guardians of the patient, by signing the informed consent.

Exclusion criteria:

1) Post-operative of recent major surgery (first 48 hours). 2) Presence of bronchopleural fistula. 3) Active bleeding or blood dyscrasias or arteriovenous or aneurysmal malformations. 4) Patient with intracranial tumor or stroke. 5) Patients with endocarditis or with a history of heart disease. 6) Unstable or catecholamine resistant septic shock, multiple organ failure. 7) Treatment with KS in the last six months. 8) Patients with some risk condition of major bleeding (contraindications established for intravenous KS). 9) Decompensated chronic disease: diabetes mellitus, heart failure, hypertension, among others. 10) Pregnant or lactating patients at the time of inclusion in the study. 11) Patients with allergies to SK or any ingredient of the formulation.

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:

3

Target sample size:

48

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:

Francisco

Last Name:

Hernández Bernal

Specialty:

Doctor of Medical Sciences, 2nd grade specialist in Hygiene and Epidemiology.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

La Habana

País:

Cuba

Zip Code:

6162

Telephone:

+537-2085887, +537-2087465

Email :

hernandez.bernal@cigb.edu.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:

Yanet

Middle Name:

de los Ángeles

Last Name:

Loret de Mola Bueno

Specialty:

Doctor in Medical Sciences; 2nd degree specialist in Intensive Care and Emergency (Pediatric Profile)

Affiliation:

Provincial Pediatric Hospital "Dr. Eduardo Agramonte Piña"

Postal Address:

Dolores Betancourt No 2 entre Domingo Puentes y Carretera de Santa Cruz

City:

Camaguey

País:

Cuba

Zip Code:

10700

Telephone:

+53-32282014

Email :

loret.cmw@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

48

Study completion date:

10/12/2021

Date of available results:

30/06/2022

Date of first publication:

30/04/2020

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:

RPCEC00000292

Date of Registration in Primary Registry:

22/10/2018

Record Verification Date:

2024/05/14

Next update date:

2025/05/14

Link to the spanish version:

Click here

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Ensayos Registrados

Proceso de Registro

DENIS Study

Acerca del RPCEC

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