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Higher versus standard dose of amoxicillin-clavulanate in pediatric protracted bacterial bronchitis: a randomized controlled study.

Higher versus standard dose of amoxicillin-clavulanate in pediatric protracted bacterial bronchitis: a randomized controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019656
Enrollment
Unknown
Registered
2018-11-21
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-11-26

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

Conditions

Pediatric protracted bacterial bronchitis

Interventions

higher dose group:45 mg/kg amoxicillin-clavulanate twice a day
standard dose group:30 mg/kg amoxicillin-clavulanate twice a day

Sponsors

The second affiliated hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
0.5 Years to 6 Years

Inclusion criteria

Inclusion criteria: Eligible subjects of this study are patients who visit the second affiliated hospital & Yuying childrens hospital because of chronic wet cough during the study period. inclusion criteria: 1. Subjects or their guardians agree to participate in this study; 2. Six months to 6 years old; 3. Diagnosed as protracted bacterial bronchitis (PBB) after screen tests; 4. Definition of PBB: 1) Presence of continuous wet chronic (>4 weeks duration) wet or productive cough; 2) Detect lower respiratory bacterial infection evidence in bronchoalveolar lavage (BALF) culture, bacterial loads?105 CFU.mL-1; 3) There is no evidence of pertussis, mycoplasma pneumoniae or chlamydia infection (According to PCR or serological examination); 4) Absence of symptoms or signs (i.e. specific cough pointers) suggestive of other causes of wet or productive cough.

Exclusion criteria

Exclusion criteria: 1. Serious neurological underdevelopment; 2. Patients with basic diseases: such as neuromuscular diseases, immune deficiency, malnutrition, heart diseases, congenital respiratory deformity, heart, brain, liver, kidney and blood system diseases, and genetic metabolic diseases; Liver function indictors (ALT, AST) more than 2 times the normal value, renal function indictor more than the normal upper limit; 3. Has received more than two weeks treatment of antibiotics; 4. Allergic to penicillin, with fever or pneumonia; 5. Poor compliance, expected difficult to complete the study; 6. With other conditions that the researcher consider inappropriate for the study.

Design outcomes

Primary

MeasureTime frame
remission rate;

Countries

China

Contacts

Public ContactZhang Hai-Lin

The second affiliated hospital of Wenzhou Medical University

zhlwz97@hotmail.com+86 13587661971

Outcome results

None listed

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