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Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI) (P-CRESCENT)

Primary Purpose

Recurrent Respiratory Tract Infections

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Pidotimod
Placebo
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Respiratory Tract Infections focused on measuring Pidotimod, Recurrent Respiratory Tract Infections, Pediatrics Study

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants having the study informed consent signed by their parent(s) / guardian. Participants will also assent specifically for their study participation signing an independent assent form. Site specific ethics requirements will be followed

  • Participants with history of respiratory tract infections (Chinese Clinical Concept and management of recurrent respiratory tract infections in children [revised] (2008) (Zhonghua er ke za zhi = Chinese journal of Pediatrics; 46 (2): 108-10) of either:

    • at least the following episodes of upper respiratory tract infections (ear/nose/throat) in the last year: 6 for those aged 3-5 years old at inclusion; 5 for those aged 6-14 years old at inclusion
    • OR at least 2 episodes of lower respiratory tract infections (trachea/bronchia/lungs) in the last 12 months
  • Participants compliant with the pidotimod Chinese approved label (package insert) requirements

Exclusion Criteria:

  • Participants with any immunodeficiency condition, either primary or secondary (including Acquired immunodeficiency syndrome [AIDS], cancers of the immune system, immune-complex disease, chemotherapy, and radiation)
  • Participants with known allergies or hypersensitivity to pidotimod or any of its excipients. Antibiotics allergic participant will not be excluded; but due warning will be given
  • Participants with immunomodulatory treatment washout period of less than 4 weeks up to baseline visit
  • Participants with any concomitant severe disease at the time of screening that are judged by the investigator that could be detrimental to the participant or could compromise the study (e.g. congenital heart disease, Rheumatic immune disease, congenital deformity of trachea, chronic pulmonary disease, chronic liver and kidney disease, etc)
  • Female pregnant or of child bearing potential, for whom the investigator suspects might maintain sexual intercourse, unless she has a negative blood pregnancy test at screening and agrees to use two methods of contraception during the study
  • Participants who has previously completed or withdrawn from this study
  • Participants with evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator's opinion
  • Participants currently enrolled in, or discontinued within the last 30 days prior to baseline from a clinical study involving an off-label/new use of an investigational drug or device, or concurrently enrolled in a non-observational clinical study or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Participants who is unreliable and unwilling to make him/herself available for the duration of the study and who will not abide by the research unit policy and procedure and study restrictions
  • Parents/Caregivers without cell phone, tablet or computer availability

Sites / Locations

  • Investigator Site 01 Children's Hospital Captial Institute of Pediatrics
  • Investigator Site 16
  • Investigator Site 09
  • Investigator Site 12
  • Investigator Site 07
  • Investigator Site 10
  • Investigator Site 14
  • Investigator Site 03
  • Investigator Site 11
  • Investigator Site 02
  • Investigator Site 06
  • Investigator Site 13
  • Investigator Site 05
  • Investigator Site 04
  • Investigator Site 08
  • Investigator Site 15

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pidotimod

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Rate of Respiratory Tract Infection (RI) per Month During Overall Study Period
The mean rate of respiratory infection episodes per month during the overall study period will be analyzed and compared between the reported groups.

Secondary Outcome Measures

Rate of Respiratory Tract Infection (RI) per Month During the Post-treatment Follow-up Period
The mean rate of RI episodes per month during the post-treatment follow-up period will be analyzed.
Rate of Respiratory Tract Infection (RI) per Month During the Double-blind Randomized Period
The RI per month during the double-blind randomized treatment period will be assessed.
Number of Days with Respiratory Tract Infections (RI) During the Double-blind Treatment Period
The number of days with RI during the double-blind treatment period will be assessed.
Number of Days with Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period
The number of days with RI during the post-treatment follow-up will be assessed.
Number of Days with Respiratory Tract Infections (RI) During the Overall Study Period
The number of days with RI during the overall period will be assessed.
Number of Antibiotic Use Days During the Double-blind Treatment Period
The number of antibiotic use days due to any respiratory infection during the double-blind treatment period will be assessed.
Number of Antibiotic Use Days During the Post-treatment Follow-up Period
The number of antibiotic use days due to any respiratory infection during the post-treatment follow-up period will be assessed.
Number of Antibiotic Use Days During the Overall Period
The number of antibiotic use days due to any respiratory infection during the overall period will be assessed.
Number of Antipyretics Use Days During the Double-blind Treatment Period
The number of antipyretics use days during the double-blind treatment period will be assessed.
Number of Antipyretics Use Days During the Post-Treatment Follow-up Period
The number of antipyretics use days due to any respiratory infection during the post-treatment follow-up period will be assessed. The number of antipyretics use days during the double-blind 60-day treatment period will be assessed.
Number of Antipyretics Use Days During the Overall Period
The number of antipyretics use days due to any respiratory infection during the overall period will be assessed.
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Double-blind Treatment Period
The percentage of participants free of RI during the double-blind treatment period will be assessed.
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period
The percentage of participants free of RI during the post-treatment follow-up period will be assessed.
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Overall Period
The percentage of participants free of RI during the overall period will be assessed.
Number of Hospitalization Days During the Double-blind Treatment Period
The number of hospitalization days due to any respiratory infection during the double-blind treatment period will be assessed.
Number of Hospitalization Days During the Post-treatment Follow-up Period
The number of hospitalization days due to any respiratory infections during the post-treatment follow-up period will be assessed.
Number of Hospitalization Days During the Overall Period
The number of hospitalization days due to any respiratory infections during the overall period will be assessed.
Percentage of Participants with At Least One Hospitalization During the Double-blind Treatment Period
The percentage of participants with at least one hospitalization due to any respiratory infections during the double-blind treatment period will be assessed.
Percentage of Participants with At Least One Hospitalization During the Post-treatment Follow-Up Period
The percentage of participants with at least one hospitalization due to any respiratory infections during the post-treatment follow-up period will be assessed.
Percentage of Participants with At Least One Hospitalization During the Overall Period
The percentage of participants with at least one hospitalization due to any respiratory infections during the overall period will be assessed.
Number of Wheezing Attack Days During the Double-blind Treatment Period
The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the double-blind treatment period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another.
Number of Wheezing Attack Days During the Post-treatment Follow-up Period
The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the post-treatment follow-up period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another.
Number of Wheezing Attack Days During the Overall Period
The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the during the overall period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another.
Number of Asthma Days During the Double-blind Treatment Period
The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the double-blind treatment period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness.
Number of Asthma Days During the Post-treatment Follow-up Period
The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the post-treatment follow-up period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness.
Number of Asthma Days During the Overall Period
The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the overall period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness.
Number of Participants with Adverse Events (AE) During the Double-blind Treatment Period
An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the double-blind treatment.
Number of Participants with Adverse Events (AE) During the Post-treatment Follow-up Period
An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the post-treatment follow- up.
Number of Participants with Adverse Events (AE) During the Overall Period
An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the overall study.

Full Information

First Posted
March 24, 2020
Last Updated
February 1, 2022
Sponsor
Almirall, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04322669
Brief Title
Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI)
Acronym
P-CRESCENT
Official Title
Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI), A Randomized, Double Blind, Placebo Controlled Clinical Trial (P-CRESCENT)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy of pidotimod as treatment in participants with recurrent respiratory tract infections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Respiratory Tract Infections
Keywords
Pidotimod, Recurrent Respiratory Tract Infections, Pediatrics Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
338 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pidotimod
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pidotimod
Intervention Description
Participants will be randomized in ratio of 1:1 to receive Pidotimod 400 milligrams (mg), once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will be randomized in ratio of 1:1 to receive placebo matched to Pidotimod, once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.
Primary Outcome Measure Information:
Title
Rate of Respiratory Tract Infection (RI) per Month During Overall Study Period
Description
The mean rate of respiratory infection episodes per month during the overall study period will be analyzed and compared between the reported groups.
Time Frame
Baseline (Day 1) up to end of post-treatment follow-up [Day 180/Early Termination (ET)]
Secondary Outcome Measure Information:
Title
Rate of Respiratory Tract Infection (RI) per Month During the Post-treatment Follow-up Period
Description
The mean rate of RI episodes per month during the post-treatment follow-up period will be analyzed.
Time Frame
From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Title
Rate of Respiratory Tract Infection (RI) per Month During the Double-blind Randomized Period
Description
The RI per month during the double-blind randomized treatment period will be assessed.
Time Frame
Baseline (Day 1) up to end of double-blind treatment (Day 60)
Title
Number of Days with Respiratory Tract Infections (RI) During the Double-blind Treatment Period
Description
The number of days with RI during the double-blind treatment period will be assessed.
Time Frame
Baseline (Day 1) up to end of double-blind treatment (Day 60)
Title
Number of Days with Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period
Description
The number of days with RI during the post-treatment follow-up will be assessed.
Time Frame
From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Days with Respiratory Tract Infections (RI) During the Overall Study Period
Description
The number of days with RI during the overall period will be assessed.
Time Frame
Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Antibiotic Use Days During the Double-blind Treatment Period
Description
The number of antibiotic use days due to any respiratory infection during the double-blind treatment period will be assessed.
Time Frame
Baseline (Day 1) up to end of double-blind treatment (Day 60)
Title
Number of Antibiotic Use Days During the Post-treatment Follow-up Period
Description
The number of antibiotic use days due to any respiratory infection during the post-treatment follow-up period will be assessed.
Time Frame
From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Antibiotic Use Days During the Overall Period
Description
The number of antibiotic use days due to any respiratory infection during the overall period will be assessed.
Time Frame
Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Antipyretics Use Days During the Double-blind Treatment Period
Description
The number of antipyretics use days during the double-blind treatment period will be assessed.
Time Frame
Baseline (Day 1) up to end of double-blind treatment (Day 60)
Title
Number of Antipyretics Use Days During the Post-Treatment Follow-up Period
Description
The number of antipyretics use days due to any respiratory infection during the post-treatment follow-up period will be assessed. The number of antipyretics use days during the double-blind 60-day treatment period will be assessed.
Time Frame
From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Antipyretics Use Days During the Overall Period
Description
The number of antipyretics use days due to any respiratory infection during the overall period will be assessed.
Time Frame
Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Title
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Double-blind Treatment Period
Description
The percentage of participants free of RI during the double-blind treatment period will be assessed.
Time Frame
Baseline (Day 1) up to end of double-blind treatment (Day 60)
Title
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period
Description
The percentage of participants free of RI during the post-treatment follow-up period will be assessed.
Time Frame
From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Title
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Overall Period
Description
The percentage of participants free of RI during the overall period will be assessed.
Time Frame
Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Hospitalization Days During the Double-blind Treatment Period
Description
The number of hospitalization days due to any respiratory infection during the double-blind treatment period will be assessed.
Time Frame
Baseline (Day 1) up to end of double-blind treatment (Day 60)
Title
Number of Hospitalization Days During the Post-treatment Follow-up Period
Description
The number of hospitalization days due to any respiratory infections during the post-treatment follow-up period will be assessed.
Time Frame
From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Hospitalization Days During the Overall Period
Description
The number of hospitalization days due to any respiratory infections during the overall period will be assessed.
Time Frame
Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Title
Percentage of Participants with At Least One Hospitalization During the Double-blind Treatment Period
Description
The percentage of participants with at least one hospitalization due to any respiratory infections during the double-blind treatment period will be assessed.
Time Frame
Baseline (Day 1) up to end of double-blind treatment (Day 60)
Title
Percentage of Participants with At Least One Hospitalization During the Post-treatment Follow-Up Period
Description
The percentage of participants with at least one hospitalization due to any respiratory infections during the post-treatment follow-up period will be assessed.
Time Frame
From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Title
Percentage of Participants with At Least One Hospitalization During the Overall Period
Description
The percentage of participants with at least one hospitalization due to any respiratory infections during the overall period will be assessed.
Time Frame
Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Wheezing Attack Days During the Double-blind Treatment Period
Description
The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the double-blind treatment period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another.
Time Frame
Baseline (Day 1) up to end of double-blind treatment (Day 60)
Title
Number of Wheezing Attack Days During the Post-treatment Follow-up Period
Description
The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the post-treatment follow-up period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another.
Time Frame
From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Wheezing Attack Days During the Overall Period
Description
The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the during the overall period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another.
Time Frame
Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Asthma Days During the Double-blind Treatment Period
Description
The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the double-blind treatment period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness.
Time Frame
Baseline (Day 1) up to end of double-blind treatment (Day 60)
Title
Number of Asthma Days During the Post-treatment Follow-up Period
Description
The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the post-treatment follow-up period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness.
Time Frame
From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Asthma Days During the Overall Period
Description
The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the overall period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness.
Time Frame
Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Participants with Adverse Events (AE) During the Double-blind Treatment Period
Description
An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the double-blind treatment.
Time Frame
Baseline (Day 1) up to end of double-blind treatment (Day 60)
Title
Number of Participants with Adverse Events (AE) During the Post-treatment Follow-up Period
Description
An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the post-treatment follow- up.
Time Frame
From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Title
Number of Participants with Adverse Events (AE) During the Overall Period
Description
An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the overall study.
Time Frame
Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants having the study informed consent signed by their parent(s) / guardian. Participants will also assent specifically for their study participation signing an independent assent form. Site specific ethics requirements will be followed Participants with history of respiratory tract infections (Chinese Clinical Concept and management of recurrent respiratory tract infections in children [revised] (2008) (Zhonghua er ke za zhi = Chinese journal of Pediatrics; 46 (2): 108-10) of either: at least the following episodes of upper respiratory tract infections (ear/nose/throat) in the last year: 6 for those aged 3-5 years old at inclusion; 5 for those aged 6-14 years old at inclusion OR at least 2 episodes of lower respiratory tract infections (trachea/bronchia/lungs) in the last 12 months Participants compliant with the pidotimod Chinese approved label (package insert) requirements Exclusion Criteria: Participants with any immunodeficiency condition, either primary or secondary (including Acquired immunodeficiency syndrome [AIDS], cancers of the immune system, immune-complex disease, chemotherapy, and radiation) Participants with known allergies or hypersensitivity to pidotimod or any of its excipients. Antibiotics allergic participant will not be excluded; but due warning will be given Participants with immunomodulatory treatment washout period of less than 4 weeks up to baseline visit Participants with any concomitant severe disease at the time of screening that are judged by the investigator that could be detrimental to the participant or could compromise the study (e.g. congenital heart disease, Rheumatic immune disease, congenital deformity of trachea, chronic pulmonary disease, chronic liver and kidney disease, etc) Female pregnant or of child bearing potential, for whom the investigator suspects might maintain sexual intercourse, unless she has a negative blood pregnancy test at screening and agrees to use two methods of contraception during the study Participants who has previously completed or withdrawn from this study Participants with evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator's opinion Participants currently enrolled in, or discontinued within the last 30 days prior to baseline from a clinical study involving an off-label/new use of an investigational drug or device, or concurrently enrolled in a non-observational clinical study or any other type of medical research judged not to be scientifically or medically compatible with this study Participants who is unreliable and unwilling to make him/herself available for the duration of the study and who will not abide by the research unit policy and procedure and study restrictions Parents/Caregivers without cell phone, tablet or computer availability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Almirall, S.A.
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site 01 Children's Hospital Captial Institute of Pediatrics
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Investigator Site 16
City
Changchun
Country
China
Facility Name
Investigator Site 09
City
Changde
Country
China
Facility Name
Investigator Site 12
City
Changsha
Country
China
Facility Name
Investigator Site 07
City
Guangzhou
Country
China
Facility Name
Investigator Site 10
City
Guilin
Country
China
Facility Name
Investigator Site 14
City
Kunming
Country
China
Facility Name
Investigator Site 03
City
Nanjing
Country
China
Facility Name
Investigator Site 11
City
Sanya
Country
China
Facility Name
Investigator Site 02
City
Shanghai
Country
China
Facility Name
Investigator Site 06
City
Shantou
Country
China
Facility Name
Investigator Site 13
City
Shaoyang
Country
China
Facility Name
Investigator Site 05
City
Tianjin
Country
China
Facility Name
Investigator Site 04
City
Xiamen
Country
China
Facility Name
Investigator Site 08
City
Yanji
Country
China
Facility Name
Investigator Site 15
City
Zhengzhou
Country
China

12. IPD Sharing Statement

Learn more about this trial

Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI)

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