Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.

Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections.

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Key information

Conditions

Lower Respiratory Tract Infection

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 16261, Bangkok, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with lower respiratory tract infection.
Patient is male or female > 6 months and < 12 years of age.
Prescription of Klacid Granules for Oral Suspension is at the discretion of the investigators according to the clinical condition of the patients
Patients who are suitable for treatment with Klacid Granules for Oral Suspension according to the Prescribing Information

Exclusion criteria

Known hypersensitivity to or previously intolerant of macrolides.
Illness severe enough to warrant hospitalization or parenteral therapy.
Concomitant use of any of the following medications:

Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.
Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.
Colchicine
Digoxin
Ritonavir.
Severe immunodeficiency and chronic disease conditions.
Renal or hepatic impairment.

Treatment and study plan

clarithromycin (Klacid) granules for oral suspension

Drug

clarithromycin (Klacid) Granules for Oral Suspension

Other names: clarithromycin, Klacid Granules for Oral Suspension, Biaxin XL

Primary outcomes

Average Time From Baseline to Recovery From Fever and Other Symptoms

Time frame: Baseline to 14 days

Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection.

Secondary outcomes

Number and Type of Adverse Events

Time frame: Baseline to 14 days

Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event are summarized. See the Reported Adverse Event section for details.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Multi-center, Post-Marketing Observational Study to Identify the Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid Granules for Oral Suspension.

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Feb 26, 2010
Registry last updated: Apr 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed