NCT04322669

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 4, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2021

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

March 24, 2020

Last Update Submit

February 1, 2022

Conditions

Recurrent Respiratory Tract Infections

Keywords

PidotimodRecurrent Respiratory Tract InfectionsPediatrics Study

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (Day 1) up to end of post-treatment follow-up [Day 180/Early Termination (ET)]

Secondary Outcomes (29)

  • Rate of Respiratory Tract Infection (RI) per Month During the Post-treatment Follow-up Period

    From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)

  • Rate of Respiratory Tract Infection (RI) per Month During the Double-blind Randomized Period

    Baseline (Day 1) up to end of double-blind treatment (Day 60)

  • Number of Days with Respiratory Tract Infections (RI) During the Double-blind Treatment Period

    Baseline (Day 1) up to end of double-blind treatment (Day 60)

  • Number of Days with Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period

    From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)

  • Number of Days with Respiratory Tract Infections (RI) During the Overall Study Period

    Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)

  • +24 more secondary outcomes

Study Arms (2)

Pidotimod

EXPERIMENTAL
Drug: Pidotimod

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PidotimodDRUG

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.

Pidotimod
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Investigator Site 01 Children's Hospital Captial Institute of Pediatrics

Beijing, 100020, China

Location

Investigator Site 16

Changchun, China

Location

Investigator Site 09

Changde, China

Location

Investigator Site 12

Changsha, China

Location

Investigator Site 07

Guangzhou, China

Location

Investigator Site 10

Guilin, China

Location

Investigator Site 14

Kunming, China

Location

Investigator Site 03

Nanjing, China

Location

Investigator Site 11

Sanya, China

Location

Investigator Site 02

Shanghai, China

Location

Investigator Site 06

Shantou, China

Location

Investigator Site 13

Shaoyang, China

Location

Investigator Site 05

Tianjin, China

Location

Investigator Site 04

Xiamen, China

Location

Investigator Site 08

Yanji, China

Location

Investigator Site 15

Zhengzhou, China

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

pidotimod

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Study Director

    Almirall, S.A.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

August 4, 2021

Primary Completion

November 4, 2021

Study Completion

November 4, 2021

Last Updated

February 2, 2022

Record last verified: 2022-02

Locations

CN(16)