Xiyanping Injection Combined With Azithromycin VS Azithromycin for Children With pneumoniaProtozoal Pneumonia

NCT04296383 | Unknown

• 1 other identifier: QF-XYP1908-1
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief Summary

Mycoplasma pneumoniae pneumonia in children is one of the major diseases in children's respiratory department in China, but there are still large clinical unmet needs.

Conditions

Mycoplasma Pneumoniae Pneumonia

Outcome Measures

Primary Outcomes (1)

• Clinical recovery time

  Time from study drug use to complete fever and cough relief, measured in days

  up to day 19

Study Arms (2)

Azithromycin plus Xiyanping injection group

EXPERIMENTAL

Drug: Azithromycin plus Xiyanping injection

Azithromycin group

ACTIVE COMPARATOR

Drug: Azithromycin

Interventions

Azithromycin plus Xiyanping injection DRUG

Azithromycin for injection is 10mg / (kg • d), the maximum dose does not exceed 0.5g / d;Xiyanping injection intravenously, 0.4mL / (kg.d) daily, Qd

Azithromycin plus Xiyanping injection group

Azithromycin DRUG

Azithromycin for injection is 10mg / (kg • d), the maximum dose does not exceed 0.5g / d

Azithromycin group

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 14 years of age at the time of screening;
• Children who meet the Western medicine clinical diagnosis standard of Mycoplasma pneumoniae and the mycoplasma pneumoniae IgM antibody titer ≥1 : 80, or Mycoplasma pneumoniae DNA or RNA (PCR) test positive, or rapid identification of Mycoplasma pneumoniae antibodies positive;
• Heat course ≤ 5 days;
• The total number of peripheral blood routine leukocytes is within the normal range;
• The child's legal guardian or / and himself voluntarily participate in the study, and the legal guardian agrees and signs the informed consent form (while children ≥8 years of age need to voluntarily sign the informed consent form);
• According to the researcher's judgment, the subject / legal guardian is believed to be reliable and able to comply with this plan, visit plan and medication arrangement.

You may not qualify if:

• Have a disease that needs to be distinguished from Mycoplasma pneumoniae pneumonia (MPP);
• Patients with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, abnormal lung development, aspiration pneumonia, lung malignancies, etc .;
• Congenital abnormalities of heart and lung, combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system, or any laboratory test indicators meet the following criteria: alanine aminotransferase (ALT), aspart Amino acid aminotransferase (AST)\> 2.0 times, serum creatinine (Cr)\> 1.5 times the upper limit of normal value (ULN);
• Those who have been diagnosed with Mycoplasma pneumoniae in the past 3 months;

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

MeSH Terms

Conditions

Pneumonia, Mycoplasma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Mycoplasma Infections; Mycoplasmatales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: June 15, 2020
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2022
• Last Updated: May 19, 2020

Record last verified: 2020-05