Biomaterial Database

Clinical multicentre trial with josamycin propionate in paediatric patients. 1984

G Privitera, and S Bonino, and S Del Mastro

Josamycin propionate, a tasteless josamycin derivative suitable for the preparation of paediatric oral suspension, was employed in a large, multicentre clinical study aimed at evaluating the effectiveness and safety of the drug. Two hundred paediatric practitioners participated in the study, and 1908 children (mean age 5.27 years) were treated. Respiratory and pararespiratory infections were the most common diagnosis. The mean daily dose of josamycin was 53.5 mg/kg and the drug was administered for an average of 7.31 days. Josamycin proved to be a highly effective antimicrobial agent for the treatment of infections occurring in paediatric practice, with a success rate of 97.1%. The drug also showed a high degree of acceptance by the young patients and was very well tolerated: only 98 children (5.14%) developed side-effects during the treatment. However, the side-effects observed were reliably attributable to josamycin in only 10 out of 300 subjects who were not receiving other drugs; among these the frequency rate was 3.33%.

UI	MeSH Term	Description	Entries
D007933	Leucomycins	An antibiotic complex produced by Streptomyces kitasatoensis. The complex consists of a mixture of at least eight biologically active components, A1 and A3 to A9. Leucomycins have both antibacterial and antimycoplasmal activities.
D008297	Male		Males
D010372	Pediatrics	A medical specialty concerned with maintaining health and providing medical care to children from birth to adolescence.
D012141	Respiratory Tract Infections	Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases.	Respiratory System Infections,Upper Respiratory Tract Infection,Upper Respiratory Tract Infections,Infections, Respiratory,Infections, Respiratory Tract,Infections, Upper Respiratory,Infections, Upper Respiratory Tract,Respiratory Infections,Upper Respiratory Infections,Infection, Respiratory System,Infection, Respiratory Tract,Respiratory Infection, Upper,Respiratory System Infection,Respiratory Tract Infection
D002648	Child	A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL.	Children
D002675	Child, Preschool	A child between the ages of 2 and 5.	Children, Preschool,Preschool Child,Preschool Children
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001424	Bacterial Infections	Infections by bacteria, general or unspecified.	Bacterial Disease,Bacterial Infection,Infection, Bacterial,Infections, Bacterial,Bacterial Diseases