Revisions for Zinc-Children-Hospitalized-Pneumonia | Registro Público Cubano de Ensayos Clínicos

--- 9 July 2020 - 2:25pm by Gladys
+++ 24 March 2023 - 7:03am by Gladys
 Zinc Sulfate
 Placebo
 Administration, Oral
-/07/09
+/10/21
-/07/09
+/10/21

Revision of 24 March 2023 - 7:03am:

Zinc-Children-Hospitalized-Pneumonia

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.

Acronym of Public Title:

ZINIHONE

Scientific title:

Zinc Sulfate as an adjuvant in a child hospitalized for pneumonia. Randomized clinical trial (ZiNiNe)

Acronym of Scientific Title:

ZiNiNe

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Autonomous Service Antonio Patricio de Alcala University Hospital (SAHUAPA)

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Elias

Midle name:

Ibrahim

Last name:

Kassisse El Hage

Medical Specialty :

Pediatrician specialist II pediatric pulmonologist

Affiliation:

Hospital Clínico Herminda Martin

Postal address:

Francisco Ramirez Avenue 10

City:

Chillan

Country:

Chile

Zip Code:

3780000

Telephone:

+56-422586400

Email address:

ekassisse@gmail.com

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:

venezuela

Clinical sites:

Not applicable

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

06/04/2017

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:

community-acquired pneumonia

Health condition(s) code:

Pneumonia

Lung Diseases

Respiratory Tract Diseases

Respiratory Tract Infections

Intervention(s):

Children hospitalized for pneumonia were divided into 2 groups Group I: experimental, received zinc sulfate orally 0.5% zinc syrup dose was 10 mg / day which corresponded to 2cc for children under 12 months of age and 20 mg / day for those over 12 months equivalent to 4cc, for 14 continuous days Group II: control, received placebo in the same volumes at the same intervals and duration

Intervention code:

Zinc Sulfate

Placebo

Administration, Oral

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):

Resolution of pneumonia (Time measured in hours required to normalize the clinical elements that defined the pneumonia). Measurement time: from the moment of admission until normal

Key secondary outcomes:

Remission rate of clinical indicators of pneumonia in percentage. Measurement time: at 72 hours’ intervention started 2. Therapeutic failure (Need to change the initial antibiotic, the appearance of complications or the persistence of hypoxemia). Measurement time: at 72 hours’ intervention started 3. Adverse effects (Any reaction related to the intervention). Measurement time: up to 14 days.

Selection criterias

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

Gender:

Male/Female

Minimum age:

one month

Maximum age:

5 years

Inclusion criteria:

1.The diagnosis of pneumonia was considered in that child with fever (T ° ≥ 38.5 ° C) in the presence of signs and symptoms such as respiratory distress, retractions or draws and cough accompanied by radiological changes.

Exclusion criteria:

The following were excluded from the study: 1. Patients with congenital malformations 2. Patients immunosuppressed by drugs or primary diseases of the immune system 3. Patients with suspected foreign body aspiration 4. Previous hospitalizations in the last 4 weeks 5. Presence of wheezing as dominant findings.

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:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

N/A

Target sample size:

200

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:

Elias

Middle Name:

Ibrahim

Last Name:

Kassisse El Hage

Specialty:

pediatrician pediatric pulmonologist

Affiliation:

Herminda Martin Clinical Hospital

Postal Address:

Francisco Ramirez avenue 10

City:

Chillan

Country:

Chile

Zip Code:

3780000.

Telephone:

+56 42 2586400

Email :

ekassisse@gmail.com

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:

Elias

Middle Name:

ibrahim

Last Name:

Kassisse El Hage

Specialty:

pediatrician Pediatric pulmonology

Affiliation:

Herminda Martin Clinical Hospital

Postal Address:

Francisco Ramirez avenue 10

City:

chillan

Country:

Chile

Zip Code:

3780000.

Telephone:

+56 42 2586400

Email :

ekassisse@gmail.com

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

200 patients

Study completion date:

23/04/2018

Date of available results:

31/07/2020

Date of first publication:

28/08/2020

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:

RPCEC00000325

Date of Registration in Primary Registry:

09/07/2020

Record Verification Date:

2020/10/21

Next update date:

2021/10/21

Link to the spanish version:

Click here

Registered Trials

Registration process

Zinc-Children-Hospitalized-Pneumonia

About the RPCEC

Useful resources