Respiratory Tract InfectionsNCT04126304
Mycoplasma Infection Rate and Macrolides Resistance in Children With Acute Respiratory Tract Infection
An observational study of Respiratory Tract Infections, run by Shanghai Children's Medical Center.
Trial summary
In recent years, mycoplasma pneumoniae caused more than 30% of respiratory infections in children in China, among which the detection rate of drug-resistant mycoplasma pneumoniae was higher than 90%. Pediatricians are facing great challenges. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Azithromycin, non-macrolides antibiotics and Mycoplasma detection
- Type of treatment
- Injection or infusion
- How many people
- 2,312 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2019to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The subjects of the study were outpatient patients at 8 centers including Shanghai children's medical center and hospitalized children at 6 centers on Oct. 28, 2019 and Sept. 27, 2020.
Who may be able to join
- age: over 28 days, under 18 years old; B) diagnosis: outpatient diagnosis of common cold, acute bronchitis or post-infection cough and hospitalization cases consistent with community-acquired pneumonia.
- the guardian of the child (< 8 years old) or the child (≥8 years old) can understand and be willing to participate in this study and sign a written informed consent.
Who cannot join
- A)It is necessary to exclude underlying diseases associated with cardiovascular system, digestive system, nervous system, endocrine system, urinary system, immune system and genetic or chromosomal abnormalities.
- the children or their families refused to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Multi-center Investigation and Study of Mycoplasma Pneumoniae Infection and Macrolide Drug Resistance in Outpatient and In-hospital Pediatric Acute Respiratory Diseases Illness in China
In recent years, mycoplasma pneumoniae caused more than 30% of respiratory infections in children in China, among which the detection rate of drug-resistant mycoplasma pneumoniae was higher than 90%. Pediatricians are facing great challenges.
In this study, a total of 2312 clinical cases were expected to be collected, including 1160 cases of outpatient respiratory infection including common cold, acute bronchitis and cough after infection, and 1152 cases of hospitalized community-acquired pneumonia, through uniform enrollment in 11 multi-centers for 1 year. Clinical data and respiratory samples were collected and clinical follow-up was completed.To investigate the infection rate and drug resistance gene of mycoplasma pneumoniae in children's respiratory tract infection.To evaluate the effectiveness of azithromycin in the treatment of mycoplasma pneumoniae respiratory infection.The early prediction model of refractory mycoplasma pneumoniae was established.To explore the clinical value of colloidal gold in early diagnosis of mycoplasma pneumoniae infection
Read the detailed description
This research center is a cross-sectional investigation and study, 8 centers including Shanghai children's medical center recruit the outpatient respiratory infection cases into the group, 6 centers including Shanghai children's medical recruit children with community-acquired pneumonia in hospital into the group All of the above cases in the group relevant clinical datas are collected, and complete clinical follow-up.Pharyngeal swabs or sputum specimens collected during the study were sent to Shanghai children's medical center for the detection of MP and macrolidene drug resistance genes.
Azithromycin was administered orally or intravenously to outpatients who tested positive for mycoplasma pneumoniae by colloidal gold method.Finally, MP infection rate of children with respiratory diseases including outpatient (common cold, acute bronchitis and cough after infection) and hospitalization (community-acquired pneumonia) was statistically observed.The detection rate of MP macrolides drug resistance gene was isolated from respiratory disease cases.Sensitivity and specificity of MP rapid detection method (antigen and antibody detection rapid colloidal gold method) for diagnosis of MP infection;Effectiveness of azithromycin in treatment of MRMP infection.
- Conditions
- Respiratory Tract Infections
- Being tested
- Azithromycin, non-macrolides antibiotics, Mycoplasma detection, Data collection
- Keywords
- community-acquired pneumonia, common cold, acute bronchitis, Post-infection cough, Mycoplasma infection rate, macrolides resistance
- Medical subject headings
- Respiratory Tract Infections, Community-Acquired Pneumonia, Common Cold, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
If the diagnosis is common cold, acute bronchitis or post-infection cough ，treated with non-macrolides when the mycoplasma colloidal gold test is negative, treated with azithromycin when colloidal gold test is positive.
non-macrolides antibioticsDrug
If the diagnosis is community-acquired pneumonia with negative mycoplasma antibody-granule agglutination, non-macrolides are used for treatment
Mycoplasma detectionDiagnostic test
- common cold, acute bronchitis or post-infection cough :MPlgM colloidal gold detection;Pharyngeal swab MP-RNA PCR, mutated gene detection at 2063 and 2064 site of macrolide-resistant 23S rRNA II region detection
- community-acquired pneumonia:mycoplasma antigen antibody particle agglutination detection ;Sputum MP-RNA PCR, mutated gene detection at 2063 and 2064 site of macrolide-resistant 23S rRNA II region detection
Data collectionOther
- Common cold:On enrollment, day 3 and day 7, scores were collected based on the Canadian acute respiratory diseases and influenza scale (CARIFS scale), success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate.
- Acute bronchitis :on enrollment, day 3, and day 7, the Likert 7 subscale was used to score the cough severity questionnaire, collect the success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate.
- Post-infection cough:on the day after outpatient visit, day 3, day 7, and day 14, the cough severity questionnaire (Likert 7 subscale) was used to score the success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate.
Data collectionOther
Acquisition of children hospitalized time, heating time, mixed infection, drug (azithromycin, tetracycline, quinolone) dose and use time, pulmonary complication (pleural effusion, atelectasis, necrotizing pneumonia, interstitial pneumonia, occlusive bronchitis, occlusive bronchiolitis, lung, emphysema, lung abscess, bronchiectasis, transparent), pleural puncture/drainage, bronchoscope, oxygen time, into the ICU, mechanical ventilation time, surgery, and deaths and re-visit, hospitalization, surgery and death within 30 days after discharge
| Study group | Role | What they receive |
|---|---|---|
| Common cold | A cold is a clinical diagnosis.Complaints may include a stuffy nose, sore throat, cough and headache.Objective signs are rare, but may include fever, enlarged anterior cervical lymph nodes, nasal mucosa and oropharyngeal erythema, and nasal mucus. Receives: Drug: Azithromycin; Diagnostic Test: Mycoplasma detection; Other: Data collection | |
| acute bronchitis | In 2011, the European society of respiratory diseases (ERS) defined acute disease in patients with non-chronic lung disease. Symptoms include cough, with or without expectoration of phlegm, and other symptoms and signs may indicate lower respiratory tract infection and cannot be explained by other diseases (e.g., sinusitis, asthma).The main symptoms of acute bronchitis are cough, may be accompanied by fever, fatigue, asthma and dyspnea. Receives: Drug: Azithromycin; Diagnostic Test: Mycoplasma detection; Other: Data collection | |
| Post-infection cough | The definition in the 2013 guidelines for diagnosis and treatment of chronic cough in Chinese children: cough refers to a recent history of respiratory tract infection;The cough lasted > for 4 weeks, presenting an irritating dry cough or a little white phlegm.Chest x - ray examination showed no abnormality or only increased lung veins.The pulmonary ventilation function was normal, or presented transient high airway response.Coughs are usually self-limited, and other diagnoses should be considered if the cough is more than 8 weeks old.In addition to other causes of chronic cough. Receives: Drug: Azithromycin; Diagnostic Test: Mycoplasma detection; Other: Data collection | |
| community-acquired pneumonia | According to the 2019 guidelines for the diagnosis and treatment of community-acquired pneumonia in children, it is defined as infectious pneumonia developed outside the hospital (community), including pneumonia developed after admission due to infection of pathogens with a clear incubation period outside the hospital (community). Receives: Drug: non-macrolides antibiotics; Diagnostic Test: Mycoplasma detection; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
MP infection rates
Respiratory illnesses include MP infection rates in children with outpatient (common cold, acute bronchitis, and chronic cough) and hospitalized (community-acquired pneumonia).
Measured: On enrollment 1 day
Secondary outcomes (4)
MP macrolides drug resistance gene rate
The detection rate of MP macrolides drug resistance gene was isolated from respiratory disease cases
Measured: On enrollment 1 day
Sensitivity and specificity of MP rapid detection method
Sensitivity and specificity of MP rapid detection method (antigen and antibody detection rapid colloidal gold method) for diagnosis of MP infection
Measured: On enrollment 1 day
An early prediction model of refractory MP pneumonia
An early prediction model of refractory MP pneumonia caused by MRMP was established
Measured: Community acquired pneumonia 30 days after discharge
Clinical efficacy of azithromycin
Common cold and acute bronchitis on enrollment, day 3 and day 7;Post-infection cough on the day after outpatient visit, day 3, day 7, and day 14
Measured: Common cold and acute bronchitis for 7 days ;Post-infection cough for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start28 Nov 2019 (estimated)
- Primary completion27 Sep 2020 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Children's Hospital, Tianjin Children's Hospital, Xi 'an children's hospital, Shenzhen Children's Hospital, Third Affiliated Hospital of Zhengzhou University, Shanghai Children's Hospital, Children's Hospital of Chongqing Medical University, Wuhan Children's Hospital, The First Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Yong Yin, master, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126304
- Sponsor's protocol ID
- SCMCIRB-K2019060-1
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li L, Liao X, Zhao J, Xie YM. [Interpretation of chinese clinical guidelines for acute upper respiratory tract infection in children]. Zhongguo Zhong Yao Za Zhi. 2017 Apr;42(8):1510-1513. doi: 10.19540/j.cnki.cjcmm.2017.0049. Chinese.
PubMed 29071854Leung DT, Chisti MJ, Pavia AT. Prevention and Control of Childhood Pneumonia and Diarrhea. Pediatr Clin North Am. 2016 Feb;63(1):67-79. doi: 10.1016/j.pcl.2015.08.003.
PubMed 26613689Nair H, Simoes EA, Rudan I, Gessner BD, Azziz-Baumgartner E, Zhang JSF, Feikin DR, Mackenzie GA, Moiisi JC, Roca A, Baggett HC, Zaman SM, Singleton RJ, Lucero MG, Chandran A, Gentile A, Cohen C, Krishnan A, Bhutta ZA, Arguedas A, Clara AW, Andrade AL, Ope M, Ruvinsky RO, Hortal M, McCracken JP, Madhi SA, Bruce N, Qazi SA, Morris SS, El Arifeen S, Weber MW, Scott JAG, Brooks WA, Breiman RF, Campbell H; Severe Acute Lower Respiratory Infections Working Group. Global and regional burden of hospital admissions for severe acute lower respiratory infections in young children in 2010: a systematic analysis. Lancet. 2013 Apr 20;381(9875):1380-1390. doi: 10.1016/S0140-6736(12)61901-1. Epub 2013 Jan 29.
PubMed 23369797Basarab M, Macrae MB, Curtis CM. Atypical pneumonia. Curr Opin Pulm Med. 2014 May;20(3):247-51. doi: 10.1097/MCP.0000000000000048.
PubMed 24626238Blasi F. Atypical pathogens and respiratory tract infections. Eur Respir J. 2004 Jul;24(1):171-81. doi: 10.1183/09031936.04.00135703.
PubMed 15293621Xu W, Guo L, Dong X, Li X, Zhou P, Ni Q, Zhou X, Wagner AL, Li L. Detection of Viruses and Mycoplasma pneumoniae in Hospitalized Patients with Severe Acute Respiratory Infection in Northern China, 2015-2016. Jpn J Infect Dis. 2018 Mar 22;71(2):134-139. doi: 10.7883/yoken.JJID.2017.412. Epub 2018 Feb 28.
PubMed 29491245Sondergaard MJ, Friis MB, Hansen DS, Jorgensen IM. Clinical manifestations in infants and children with Mycoplasma pneumoniae infection. PLoS One. 2018 Apr 26;13(4):e0195288. doi: 10.1371/journal.pone.0195288. eCollection 2018.
PubMed 29698412Wang H, Dai W, Qiu C, Li S, Wang W, Xu J, Li Z, Wang H, Li Y, Yang Z, Feng X, Zhou Q, Han L, Li Y, Zheng Y. Mycoplasma pneumoniae and Streptococcus pneumoniae caused different microbial structure and correlation network in lung microbiota. J Thorac Dis. 2016 Jun;8(6):1316-22. doi: 10.21037/jtd.2016.04.63.
PubMed 27293852Zhao F, Liu J, Shi W, Huang F, Liu L, Zhao S, Zhang J. Antimicrobial susceptibility and genotyping of Mycoplasma pneumoniae isolates in Beijing, China, from 2014 to 2016. Antimicrob Resist Infect Control. 2019 Jan 24;8:18. doi: 10.1186/s13756-019-0469-7. eCollection 2019.
PubMed 30697421Yang HJ, Song DJ, Shim JY. Mechanism of resistance acquisition and treatment of macrolide-resistant Mycoplasma pneumoniae pneumonia in children. Korean J Pediatr. 2017 Jun;60(6):167-174. doi: 10.3345/kjp.2017.60.6.167. Epub 2017 Jun 22.
PubMed 28690643Matsuoka M, Narita M, Okazaki N, Ohya H, Yamazaki T, Ouchi K, Suzuki I, Andoh T, Kenri T, Sasaki Y, Horino A, Shintani M, Arakawa Y, Sasaki T. Characterization and molecular analysis of macrolide-resistant Mycoplasma pneumoniae clinical isolates obtained in Japan. Antimicrob Agents Chemother. 2004 Dec;48(12):4624-30. doi: 10.1128/AAC.48.12.4624-4630.2004.
PubMed 15561835Bebear C, Pereyre S, Peuchant O. Mycoplasma pneumoniae: susceptibility and resistance to antibiotics. Future Microbiol. 2011 Apr;6(4):423-31. doi: 10.2217/fmb.11.18.
PubMed 21526943Kawai Y, Miyashita N, Kubo M, Akaike H, Kato A, Nishizawa Y, Saito A, Kondo E, Teranishi H, Wakabayashi T, Ogita S, Tanaka T, Kawasaki K, Nakano T, Terada K, Ouchi K. Nationwide surveillance of macrolide-resistant Mycoplasma pneumoniae infection in pediatric patients. Antimicrob Agents Chemother. 2013 Aug;57(8):4046-9. doi: 10.1128/AAC.00663-13. Epub 2013 May 28.
PubMed 23716043Yin YD, Wang R, Zhuo C, Wang H, Wang MG, Xie CM, She DY, Yuan X, Wang RT, Cao B, Liu YN. Macrolide-resistant Mycoplasma pneumoniae prevalence and clinical aspects in adult patients with community-acquired pneumonia in China: a prospective multicenter surveillance study. J Thorac Dis. 2017 Oct;9(10):3774-3781. doi: 10.21037/jtd.2017.09.75.
PubMed 29268385Lee E, Cho HJ, Hong SJ, Lee J, Sung H, Yu J. Prevalence and clinical manifestations of macrolide resistant Mycoplasma pneumoniae pneumonia in Korean children. Korean J Pediatr. 2017 May;60(5):151-157. doi: 10.3345/kjp.2017.60.5.151. Epub 2017 May 31.
PubMed 28592978
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Investigation and Study of Mycoplasma Pneumoniae Infection and Macrolide Drug Resistance in Outpatient and In-hospital Pediatric Acute Respiratory Diseases Illness in China
- ClinicalTrials.gov ID
- NCT04126304
- Acronym / sponsor ID
- SCMCIRB-K2019060-1
- Conditions
- Respiratory Tract Infections
- Keywords
- community-acquired pneumonia, common cold, acute bronchitis, Post-infection cough, Mycoplasma infection rate, macrolides resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,312 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Collaborators
- Beijing Children's Hospital, Tianjin Children's Hospital, Xi 'an children's hospital, Shenzhen Children's Hospital, Third Affiliated Hospital of Zhengzhou University, Shanghai Children's Hospital, Children's Hospital of Chongqing Medical University, Wuhan Children's Hospital, The First Affiliated Hospital of Guangzhou Medical University
- Study start
- 28 Nov 2019 (estimated)
- Primary completion
- 27 Sep 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, mycoplasma pneumoniae caused more than 30% of respiratory infections in children in China, among which the detection rate of drug-resistant mycoplasma pneumoniae was higher than 90%. Pediatricians are facing great challenges.
In this study, a total of 2312 clinical cases were expected to be collected, including 1160 cases of outpatient respiratory infection including common cold, acute bronchitis and cough after infection, and 1152 cases of hospitalized community-acquired pneumonia, through uniform enrollment in 11 multi-centers for 1 year. Clinical data and respiratory samples were collected and clinical follow-up was completed.To investigate the infection rate and drug resistance gene of mycoplasma pneumoniae in children's respiratory tract infection.To evaluate the effectiveness of azithromycin in the treatment of mycoplasma pneumoniae respiratory infection.The early prediction model of refractory mycoplasma pneumoniae was established.To explore the clinical value of colloidal gold in early diagnosis of mycoplasma pneumoniae infection
Detailed description
This research center is a cross-sectional investigation and study, 8 centers including Shanghai children's medical center recruit the outpatient respiratory infection cases into the group, 6 centers including Shanghai children's medical recruit children with community-acquired pneumonia in hospital into the group All of the above cases in the group relevant clinical datas are collected, and complete clinical follow-up.Pharyngeal swabs or sputum specimens collected during the study were sent to Shanghai children's medical center for the detection of MP and macrolidene drug resistance genes.
Azithromycin was administered orally or intravenously to outpatients who tested positive for mycoplasma pneumoniae by colloidal gold method.Finally, MP infection rate of children with respiratory diseases including outpatient (common cold, acute bronchitis and cough after infection) and hospitalization (community-acquired pneumonia) was statistically observed.The detection rate of MP macrolides drug resistance gene was isolated from respiratory disease cases.Sensitivity and specificity of MP rapid detection method (antigen and antibody detection rapid colloidal gold method) for diagnosis of MP infection;Effectiveness of azithromycin in treatment of MRMP infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Common cold | – | Drug: Azithromycin, Diagnostic Test: Mycoplasma detection, Other: Data collectionA cold is a clinical diagnosis.Complaints may include a stuffy nose, sore throat, cough and headache.Objective signs are rare, but may include fever, enlarged anterior cervical lymph nodes, nasal mucosa and oropharyngeal erythema, and nasal mucus. |
| acute bronchitis | – | Drug: Azithromycin, Diagnostic Test: Mycoplasma detection, Other: Data collectionIn 2011, the European society of respiratory diseases (ERS) defined acute disease in patients with non-chronic lung disease. Symptoms include cough, with or without expectoration of phlegm, and other symptoms and signs may indicate lower respiratory tract infection and cannot be explained by other diseases (e.g., sinusitis, asthma).The main symptoms of acute bronchitis are cough, may be accompanied by fever, fatigue, asthma and dyspnea. |
| Post-infection cough | – | Drug: Azithromycin, Diagnostic Test: Mycoplasma detection, Other: Data collectionThe definition in the 2013 guidelines for diagnosis and treatment of chronic cough in Chinese children: cough refers to a recent history of respiratory tract infection;The cough lasted > for 4 weeks, presenting an irritating dry cough or a little white phlegm.Chest x - ray examination showed no abnormality or only increased lung veins.The pulmonary ventilation function was normal, or presented transient high airway response.Coughs are usually self-limited, and other diagnoses should be considered if the cough is more than 8 weeks old.In addition to other causes of chronic cough. |
| community-acquired pneumonia | – | Drug: non-macrolides antibiotics, Diagnostic Test: Mycoplasma detection, Other: Data collectionAccording to the 2019 guidelines for the diagnosis and treatment of community-acquired pneumonia in children, it is defined as infectious pneumonia developed outside the hospital (community), including pneumonia developed after admission due to infection of pathogens with a clear incubation period outside the hospital (community). |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The subjects of the study were outpatient patients at 8 centers including Shanghai children's medical center and hospitalized children at 6 centers on Oct. 28, 2019 and Sept. 27, 2020.
Key inclusion criteria (2 listed)
- age: over 28 days, under 18 years old; B) diagnosis: outpatient diagnosis of common cold, acute bronchitis or post-infection cough and hospitalization cases consistent with community-acquired pneumonia.
- the guardian of the child (< 8 years old) or the child (≥8 years old) can understand and be willing to participate in this study and sign a written informed consent.
Key exclusion criteria (2 listed)
- A)It is necessary to exclude underlying diseases associated with cardiovascular system, digestive system, nervous system, endocrine system, urinary system, immune system and genetic or chromosomal abnormalities.
- the children or their families refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinIf the diagnosis is common cold, acute bronchitis or post-infection cough ，treated with non-macrolides when the mycoplasma colloidal gold test is negative, treated with azithromycin when colloidal gold test is positive. | Drug | Common cold, Post-infection cough, acute bronchitis |
| non-macrolides antibioticsIf the diagnosis is community-acquired pneumonia with negative mycoplasma antibody-granule agglutination, non-macrolides are used for treatment | Drug | community-acquired pneumonia |
| Mycoplasma detection1. common cold, acute bronchitis or post-infection cough :MPlgM colloidal gold detection;Pharyngeal swab MP-RNA PCR, mutated gene detection at 2063 and 2064 site of macrolide-resistant 23S rRNA II region detection 2. community-acquired pneumonia:mycoplasma antigen antibody particle agglutination detection ;Sputum MP-RNA PCR, mutated gene detection at 2063 and 2064 site of macrolide-resistant 23S rRNA II region detection | Diagnostic test | Common cold, Post-infection cough, acute bronchitis, community-acquired pneumonia |
| Data collection1. Common cold:On enrollment, day 3 and day 7, scores were collected based on the Canadian acute respiratory diseases and influenza scale (CARIFS scale), success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate. 2. Acute bronchitis :on enrollment, day 3, and day 7, the Likert 7 subscale was used to score the cough severity questionnaire, collect the success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate. 3. Post-infection cough:on the day after outpatient visit, day 3, day 7, and day 14, the cough severity questionnaire (Likert 7 subscale) was used to score the success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate. | Other | Common cold, Post-infection cough, acute bronchitis |
| Data collectionAcquisition of children hospitalized time, heating time, mixed infection, drug (azithromycin, tetracycline, quinolone) dose and use time, pulmonary complication (pleural effusion, atelectasis, necrotizing pneumonia, interstitial pneumonia, occlusive bronchitis, occlusive bronchiolitis, lung, emphysema, lung abscess, bronchiectasis, transparent), pleural puncture/drainage, bronchoscope, oxygen time, into the ICU, mechanical ventilation time, surgery, and deaths and re-visit, hospitalization, surgery and death within 30 days after discharge | Other | community-acquired pneumonia |
Primary outcome
MP infection rates
Time frame: On enrollment 1 day
Respiratory illnesses include MP infection rates in children with outpatient (common cold, acute bronchitis, and chronic cough) and hospitalized (community-acquired pneumonia).
4 secondary outcomes
MP macrolides drug resistance gene rate
Time frame: On enrollment 1 day
Sensitivity and specificity of MP rapid detection method
Time frame: On enrollment 1 day
An early prediction model of refractory MP pneumonia
Time frame: Community acquired pneumonia 30 days after discharge
Clinical efficacy of azithromycin
Time frame: Common cold and acute bronchitis for 7 days ;Post-infection cough for 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Background: PubMed 29071854Li L, Liao X, Zhao J, Xie YM. [Interpretation of chinese clinical guidelines for acute upper respiratory tract infection in children]. Zhongguo Zhong Yao Za Zhi. 2017 Apr;42(8):1510-1513. doi: 10.19540/j.cnki.cjcmm.2017.0049. Chinese.
- Results publication: PubMed 26613689Leung DT, Chisti MJ, Pavia AT. Prevention and Control of Childhood Pneumonia and Diarrhea. Pediatr Clin North Am. 2016 Feb;63(1):67-79. doi: 10.1016/j.pcl.2015.08.003.
- Results publication: PubMed 23369797Nair H, Simoes EA, Rudan I, Gessner BD, Azziz-Baumgartner E, Zhang JSF, Feikin DR, Mackenzie GA, Moiisi JC, Roca A, Baggett HC, Zaman SM, Singleton RJ, Lucero MG, Chandran A, Gentile A, Cohen C, Krishnan A, Bhutta ZA, Arguedas A, Clara AW, Andrade AL, Ope M, Ruvinsky RO, Hortal M, McCracken JP, Madhi SA, Bruce N, Qazi SA, Morris SS, El Arifeen S, Weber MW, Scott JAG, Brooks WA, Breiman RF, Campbell H; Severe Acute Lower Respiratory Infections Working Group. Global and regional burden of hospital admissions for severe acute lower respiratory infections in young children in 2010: a systematic analysis. Lancet. 2013 Apr 20;381(9875):1380-1390. doi: 10.1016/S0140-6736(12)61901-1. Epub 2013 Jan 29.
- Results publication: PubMed 24626238Basarab M, Macrae MB, Curtis CM. Atypical pneumonia. Curr Opin Pulm Med. 2014 May;20(3):247-51. doi: 10.1097/MCP.0000000000000048.
- Results publication: PubMed 15293621Blasi F. Atypical pathogens and respiratory tract infections. Eur Respir J. 2004 Jul;24(1):171-81. doi: 10.1183/09031936.04.00135703.
- Results publication: PubMed 29491245Xu W, Guo L, Dong X, Li X, Zhou P, Ni Q, Zhou X, Wagner AL, Li L. Detection of Viruses and Mycoplasma pneumoniae in Hospitalized Patients with Severe Acute Respiratory Infection in Northern China, 2015-2016. Jpn J Infect Dis. 2018 Mar 22;71(2):134-139. doi: 10.7883/yoken.JJID.2017.412. Epub 2018 Feb 28.
- Results publication: PubMed 29698412Sondergaard MJ, Friis MB, Hansen DS, Jorgensen IM. Clinical manifestations in infants and children with Mycoplasma pneumoniae infection. PLoS One. 2018 Apr 26;13(4):e0195288. doi: 10.1371/journal.pone.0195288. eCollection 2018.
- Results publication: PubMed 27293852Wang H, Dai W, Qiu C, Li S, Wang W, Xu J, Li Z, Wang H, Li Y, Yang Z, Feng X, Zhou Q, Han L, Li Y, Zheng Y. Mycoplasma pneumoniae and Streptococcus pneumoniae caused different microbial structure and correlation network in lung microbiota. J Thorac Dis. 2016 Jun;8(6):1316-22. doi: 10.21037/jtd.2016.04.63.
- Results publication: PubMed 30697421Zhao F, Liu J, Shi W, Huang F, Liu L, Zhao S, Zhang J. Antimicrobial susceptibility and genotyping of Mycoplasma pneumoniae isolates in Beijing, China, from 2014 to 2016. Antimicrob Resist Infect Control. 2019 Jan 24;8:18. doi: 10.1186/s13756-019-0469-7. eCollection 2019.
- Results publication: PubMed 28690643Yang HJ, Song DJ, Shim JY. Mechanism of resistance acquisition and treatment of macrolide-resistant Mycoplasma pneumoniae pneumonia in children. Korean J Pediatr. 2017 Jun;60(6):167-174. doi: 10.3345/kjp.2017.60.6.167. Epub 2017 Jun 22.
- Results publication: PubMed 15561835Matsuoka M, Narita M, Okazaki N, Ohya H, Yamazaki T, Ouchi K, Suzuki I, Andoh T, Kenri T, Sasaki Y, Horino A, Shintani M, Arakawa Y, Sasaki T. Characterization and molecular analysis of macrolide-resistant Mycoplasma pneumoniae clinical isolates obtained in Japan. Antimicrob Agents Chemother. 2004 Dec;48(12):4624-30. doi: 10.1128/AAC.48.12.4624-4630.2004.
- Results publication: PubMed 21526943Bebear C, Pereyre S, Peuchant O. Mycoplasma pneumoniae: susceptibility and resistance to antibiotics. Future Microbiol. 2011 Apr;6(4):423-31. doi: 10.2217/fmb.11.18.
- Individual participant dataSharing planned: Undecided
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Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Yin, master principal investigator
Shanghai Children's Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections, run by Shanghai Children's Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Yin, Master (18930830705, E-mail:yinyong9999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MP infection rates (time frame: On enrollment 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04126304, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.