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OpenTrials
Completed

NCT Number: NCT01076153

Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.

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Key information

Conditions

Respiratory Tract Infection Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 22862, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with upper or lower respiratory tract infection.
  • Patient is male or female ≥ 18 years of age.

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
  • Some antiretrovirals: zidovudine and ritonavir.
  • Severe immunodeficiency and chronic disease conditions.
  • Renal or hepatic impairment.

Treatment and study plan

Clarithromycin (Klacid® MR)

Drug

Klacid MR 500mg (clarithromycin)

Other names: Clarithromycin, Klacid MR, Biaxin XL

Primary outcomes

  1. Average Time From Baseline to Recovery From Cough and Other Symptoms

    Time frame: Baseline to 14 days

    Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) 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, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection.

Secondary outcomes

  1. 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 is 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 Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 26, 2010
Registry last updated
Jul 12, 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.

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