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

A Randomized, Double-blind, Parallel-controlled,Multicenter Clinical Study of Xiyanping Injection Combined With Azithromycin and Azithromycin for Children With Pneumonia

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.

Study Overview

• Status: Unknown
• Conditions: Mycoplasma Pneumoniae Pneumonia
• Intervention / Treatment: Drug: Azithromycin plus Xiyanping injection; Drug: Azithromycin

Detailed Description

In order to further verify the clinical value and safety of Xiyanping injection in children with Mycoplasma pneumoniae pneumonia, to provide references for subsequent confirmatory research, and to provide more reasonable and standardized application guidance and basis for clinical practice, we intend to adopt more rigorous Scientific design to carry out a multi-center, randomized, double-blind, parallel-controlled study of Xiyanping injection in the treatment of children with Mycoplasma pneumoniae pneumonia.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 5 to 14 years of age at the time of screening;
2. 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;
3. Heat course ≤ 5 days;
4. The total number of peripheral blood routine leukocytes is within the normal range;
5. 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);
6. 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.

Exclusion Criteria:

1. Have a disease that needs to be distinguished from Mycoplasma pneumoniae pneumonia (MPP);
2. Patients with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, abnormal lung development, aspiration pneumonia, lung malignancies, etc .;
3. 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);
4. Those who have been diagnosed with Mycoplasma pneumoniae in the past 3 months;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Azithromycin plus Xiyanping injection group	Drug: Azithromycin plus Xiyanping injection; 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
ACTIVE_COMPARATOR: Azithromycin group	Drug: Azithromycin; Azithromycin for injection is 10mg / (kg • d), the maximum dose does not exceed 0.5g / d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical recovery time	Time from study drug use to complete fever and cough relief, measured in days	up to day 19

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 15, 2020
• Primary Completion (ANTICIPATED): August 15, 2021
• Study Completion (ANTICIPATED): August 15, 2022

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (ACTUAL): March 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 17, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia, Bacterial; Mycoplasmatales Infections; Mycoplasma Infections; Pneumonia; Pneumonia, Mycoplasma; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: QF-XYP1908-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No