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Multicenter real world study for large dose of ambroxol in the treatment of infant pertussis

Multicenter real world study for large dose of ambroxol in the treatment of infant pertussis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019546
Enrollment
Unknown
Registered
2018-11-18
Start date
2018-11-07
Completion date
Unknown
Last updated
2018-11-19

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

Conditions

Pertussis

Interventions

Control group:Suggestions on diagnosis and treatment of pertussis in Chinese children in 2017
High dose group:Suggestions on diagnosis and treatment of pertussis in Chinese children in 2017 as well Intravenous infusion of ambroxol (ambroxol hydrochloride injection) at 10mg/kg per time, bid.

Sponsors

The Second Affiliated Hospital of Shantou University Medical College(Pediatrics)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1) Typical cases are accompanied by paroxysmal and spasmodic cough, and continuous cough more than 2 weeks; 2) Atypical cases with recurrent apnea, asphyxia, purple and bradycardia, or intermittent paroxysmal cough; 3) Laboratory test is showed that peripheral blood leukocyte count and lymphocytes significantly increasing 4) Satisfy any of the above items 1 and 2, or accompany the third item, and satisfy the following items 5, 6 and 7; 5) No more than 1 year old, male or female; 6) Agreeing to cooperate with the drug according to the requirements of the test program; 7) With the informed consent of the legal guardian and the agreement of the child,then signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) Anyone who has severe respiratory failure, requiring mechanical ventilation; 2) Anyone who has congenital heart disease; 3) Anyone who has central nervous system infection; 4) Anyone who has severe renal insufficiency; 5) Anyone who has a history of liver disease; 6) Anyone who has epilepsy or febrile convulsions; 7) Anyone who has severely malnourished; 8) Anyone who has malignant tumors; 9)Anyone who has clearly allergic to the tested drugs; 10) Anyone who is treated by a testing scheme within 3 months.

Design outcomes

Primary

MeasureTime frame
The Integral for spasmodic cough;

Countries

China

Contacts

Public ContactXiaohua Zhou

The Second Affiliated Hospital of Shantou University Medical College(Pediatrics)

85748527@qq.com+86 13790830191

Outcome results

None listed

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