Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections — DoSe iT

Otitis Media Clinical Trial

Official title:
Comparison of Treatment Satisfaction and Treatment Adherence of a Novel Application Form "Dose Sipping Technology" (DST) of Oral Clarithromycin vs. Clarithromycin Syrup in Children Suffering From Acute Otitis Media, Tonsillitis, Pharyngitis, or Acute Bacterial Bronchitis (DoSe iT)

Status Completed

Clinical Trial Summary

This study was performed in children with upper respiratory tract infections (acute ear infection, infection of the tonsils or throat, or bacterial inflammation of the bronchi) who needed treatment with an antibiotic (clarithromycin). The study investigated a new technology which delivers the antibiotic in a straw (dose sipping technology, DST) in comparison to a marketed syrup.

Clinical Trial Description

The study population were children aged 2-12 years (weight 12-40 kg) suffering from upper respiratory tract infections (acute otitis media, tonsillitis, pharyngitis, or acute bacterial bronchitis) and who needed antibiotic treatment. The study compared treatment satisfaction and treatment adherence of oral clarithromycin DST (125 mg, 187.5 mg, or 250 mg twice daily) with the established oral clarithromycin syrup administered via a graduated syringe (Klacid Syrup Forte®, 250 mg/5mL) at the same fixed daily doses.

Fixed doses of 125 mg, 187.5 mg and 250 mg of clarithromycin DST offer the pediatrician the flexibility to treat children of different body weight and age adequately at the recommended daily dose of 15 (12.5-20) mg/kg. All children were treated for 7 to 10 day (14 to 20 doses). Treatment satisfaction by the guardian/caregiver in terms of handling and administration of the clarithromycin DST straw and the comparator clarithromycin syrup, convenience of the administration, acceptance of taste and aftertaste, and treatment satisfaction with respect to future use was evaluated by means of a Parents' Questionnaire once on either Day 3, 4, or 5 and once on either Day 11, 12, 13, or 14. In addition, treatment adherence/willingness of medication intake and the child's health status were assessed. The safety program comprised recording and evaluation of adverse events and countermeasures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04016051
Study type	Interventional
Source	Grünenthal GmbH
Contact
Status	Completed
Phase	Phase 3
Start date	September 22, 2004
Completion date	December 23, 2004

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02452164` - Family MobilePhone Otoscopy in Diagnostics of Otitis Media	N/A
Completed	`NCT01199016` - Effect of Prevnar 13 on Ear Infections in Children	Phase 4
Terminated	`NCT00778063` - Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients	N/A
Completed	`NCT00195611` - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media	Phase 4
Recruiting	`NCT03722160` - Clinical Study of the Solo Tympanostomy Tube Device	N/A
Recruiting	`NCT04447521` - Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
Active, not recruiting	`NCT05127161` - Broad Implementation of Outpatient Stewardship	N/A
Completed	`NCT02600559` - Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes	Phase 3
Completed	`NCT01444391` - inVENT-visIOn Study	N/A
Enrolling by invitation	`NCT01437436` - The Effect of Obesity on Ventilation Tube Insertion	N/A
Completed	`NCT01003210` - Homeopathic Ear Drops for Otitis Media Study	N/A
Completed	`NCT00768534` - Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media	N/A
Recruiting	`NCT00393159` - The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children	Phase 4
Completed	`NCT00617682` - Maternal Immunization To Prevent Infant Otitis Media	Phase 1/Phase 2
Withdrawn	`NCT00956748` - N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media	Phase 4
Withdrawn	`NCT01908764` - Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery	Phase 1
Recruiting	`NCT01619462` - Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children	Phase 3
Completed	`NCT02616458` - The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population	N/A
Completed	`NCT00044473` - A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat	Phase 3
Completed	`NCT00051753` - Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.