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Randomized controlled study of azithromycin in treatment of mycoplasma pneumoniae pneumonia in children

Randomized controlled study of azithromycin in treatment of mycoplasma pneumoniae pneumonia in children

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080889
Enrollment
Unknown
Registered
2024-02-16
Start date
2022-05-04
Completion date
Unknown
Last updated
2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired pneumonia in children

Interventions

Model solution group:Intravenous infusion of azithromycin, 15 mg/kg on day 1 and 10 mg/kg on day 2-5
Conventional solution group:Intravenous infusion of azithromycin, 10 mg/kg daily for 5 days

Sponsors

Baoding Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 18 Years

Inclusion criteria

Inclusion criteria: 1) Age 1 month to 18 years; 2) The CAP diagnostic criteria; 3) Suitable for intravenous AZM treatment and the duration of AZM treatment is estimated at least five days; 4) ICF signed by the guardians of the participants. Children aged of 8-18 years old must sign the ICF personally.

Exclusion criteria

Exclusion criteria: 1) Hypersensitivity to AZM; 2) Incomplete AZM dose information or clinical information; 3) Hospital-acquired pneumonia (HAP, pneumonia that occurred 48 hours after admission with no diagnosis of pneumonia before admission) or ventilator-associated pneumonia (VAP, pneumonia that occurred 48 to 72 hours after mechanical ventilation); 4) Multiple episodes of CAP in the same patient; 5) Children with any comorbidity of meningitis, tuberculosis, immunosuppression, acute malnutrition or symptoms indicating chronic illness; 6) Corrected QT interval (QTc) is greater than 440 ms on electrocardiogram (ECG); 7) The patient participating in other clinical trials or receiving other antibiotics with a similar antibacterial spectrum to AZM (including third generation cephalosporins, carbapenems, and so on); 8) Having other factors that researchers believe are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Blood drug concentration;

Secondary

MeasureTime frame
Liver function;Renal function;White blood cells;C-reactive protein;

Countries

China

Contacts

Public ContactAdong Shen; Bi Jing

Baoding Children's Hospital

shenad16@hotmail.com+86 133 7011 5087

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026