Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04600752
Other study ID # 213514
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 7, 2022
Est. completion date November 12, 2022

Study information

Verified date May 2024
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses. Most physicians in India use the standard Augmentin (amoxicillin:clavulanic acid 7:1) (45/6.4 mg/kg/day) formulation and double the dose to achieve higher dose of amoxicillin/clavulanic acid at 90 mg/kg/day in pediatric acute otitis media (AOM) due to non-availability of Augmentin (ES)-600. Using the 7:1 formulation causes unnecessary exposure to higher proportionate dose of clavulanic acid (12.8 mg/kg/day) as a unit dose of 6.4 mg/kg/day of clavulanic acid is only required for efficacy against beta-lactamase producing AOM pathogens. Hence, there is an unmet need for availability of Augmentin (ES)-600 in India. This is an open label, single arm, multicenter, non-comparative study in participants aged 6 months to 12 years with AOM. It aims to assess the safety and clinical efficacy of Augmentin (ES)-600 administered in two divided doses, every 12 hours in pediatric population in India. AUGMENTIN is a registered trademark of the GlaxoSmithKline group of companies.


Recruitment information / eligibility

Status Completed
Enrollment 310
Est. completion date November 12, 2022
Est. primary completion date November 12, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Months to 12 Years
Eligibility Inclusion Criteria: - Participants aged: 6 months to 12 years; no gender restriction. - Diagnosis of AOM on basis of otoscopic findings as defined below: 1. Purulent otorrhea of less than 24 hours duration or 2. Middle ear effusion - Middle ear effusion is evidenced by at least two of the following: 1. Decreased or absent tympanic mobility measured by pneumatic otoscopy, 2. Yellow or white discoloration of the tympanic membrane, or 3. Opacification of the tympanic membrane plus At least one of the following indicators of acute inflammation: 1. Ear pain within 24 hours, including unaccustomed tugging or rubbing of ear, 2. Marked redness of the tympanic membrane, or 3. Distinct fullness or bulging of the tympanic membrane. - The participant and parent(s)/legal guardian(s) are willing and able to comply with the study protocol. - In accordance with regional/local laws and regulations, the parent(s)/legal guardian(s) has given signed informed, dated consent; and the participant has given written assent, if applicable, to participate in the study. Exclusion Criteria: - Weight more than 40 kg. - Spontaneous perforation of the tympanic membrane and drainage for longer than 24 hours. - Tympanoplastic tube(s) in place, or has anatomic abnormalities associated with recurrent AOM, prolonged middle ear effusion, including cleft palate or repair, high-arched palate or Down's syndrome. - A serious underlying disease as per clinician's judgment. - Concomitant infection which would preclude evaluation of the response of his/her acute otitis media to the study intervention. - Pre-existing renal insufficiency (plasma creatinine greater than [>]1.5 times upper limit of normal range for age). - Pre-existing liver disease(s) and/or hepatic dysfunction. - Evidence of leukopenia and/or thrombocytopenia. - History of previous hypersensitivity reaction to penicillins, cephalosporins or other beta-lactam antibiotics. - History of Augmentin-associated cholestatic jaundice/hepatic dysfunction. - History of phenylketonuria or a known hypersensitivity to aspartame. - Received, within 48 hours of study entry, or is scheduled to receive during the study period, any medication which may alter bowel function. - Currently receiving or has received more than one dose of systemic antibiotic therapy within one week prior to the initiation of the study. AOM treatment failures with Amoxicillin, erythromycin, sulfamethoxazole or Trimethoprim-Sulfamethoxazole are not subject to this criterion. - Receipt of an investigational compound (non-Food and Drug Administration [FDA] and non- Drugs Controller General Of India [DCGI] approved) or device within the previous 30 days or five half-lives, whichever is longer, preceding the first dose of study intervention or during the study. - Participants with symptoms suggestive of active Coronavirus Disease 2019 (COVID-19) infection (fever, cough, etc). - Participants with known COVID-19 positive contacts within the past 14 days.

Study Design


Intervention

Drug:
Augmentin (ES)-600
Augmentin ES will be administered as reconstituted oral suspension containing Amoxicillin and Potassium Clavulanate 600 mg/42.9 mg per 5 milliliters.

Locations

Country Name City State
India GSK Investigational Site Belgaun
India GSK Investigational Site Hyderabad
India GSK Investigational Site Jaipur Rajasthan
India GSK Investigational Site Kanpur
India GSK Investigational Site Kolkata
India GSK Investigational Site Ludhiana
India GSK Investigational Site Madurai
India GSK Investigational Site Nagpur
India GSK Investigational Site New Delhi
India GSK Investigational Site Pune
India GSK Investigational Site Purne
India GSK Investigational Site Raipur Chhattisgarh
India GSK Investigational Site Varanasi Uttar Pradesh

Sponsors (2)

Lead Sponsor Collaborator
GlaxoSmithKline Iqvia Pty Ltd

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment-emergent Adverse Events (TEAEs) An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A treatment emergent AE event has its onset date on or after treatment start date and on or before treatment stop date + 1 day Up to 28 days
Secondary Number of Participants With Early Clinical Response at On-therapy (OT) Visit Early clinical response was categorized as treatment 'success' or treatment 'failure' at OT Visit (Day 3 to 5). Success was defined as 'clinical cure' that included sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy was indicated or 'improvement' that included improvement in at least 1 presenting signs/symptoms such that no additional antibiotic indicated. Failure is defined as 'Clinical Failure' that included as non-improvement or deterioration in any sign/symptoms after 2 or more days of therapy and additional antibiotic therapy is indicated or 'Unable to Determine' included a valid assessment of clinical outcome could not be made (eg, participant did not attend or consent to clinical examination or lost to follow-up). Participants who were not taking minimum 4 doses in two days were categorized as non evaluable. On-therapy (OT) visit (Day 3 to 5)
Secondary Number of Participants With Primary Clinical Response at End of Therapy (EOT) Primary clinical response at the end-of-therapy visit was categorized as treatment 'success' or treatment 'failure'. Success was defined as 'Clinical Cure' that included sufficient resolution or improvement of the signs and symptoms that no additional antibiotic therapy was indicated or 'Improvement' that included improvement, but incomplete resolution of presenting signs/symptoms and no additional antibiotic indicated. Failure is defined as 'Clinical Failure' that included non-improvement or deterioration in any sign/symptoms after 2 or more days of therapy and additional antibiotic therapy indicated, or 'Unable to determine' defined as a valid assessment of clinical outcome could not be made (e.g., participant did not attend or consent to clinical examination or lost to follow-up). Non-Evaluable is defined as participants who had less than (<) 80% compliance End of therapy visit (Day 12 to 14)
Secondary Number of Participants With Secondary Clinical Response at Follow-up (FU) Secondary clinical response at follow-up was categorized as treatment 'success' or treatment 'failure'. Success was defined as 'Persistent clinical cure' that included sufficient resolution of signs/symptoms for those participants who were clinically cured or improved at the end of therapy and no additional antibiotic indicated. Failure was defined as 'Clinical recurrence' that included reappearance of signs/symptoms for those participants who were clinically cured or improved at the end of therapy and additional antibiotic therapy was indicated, or 'Unable to determine' that included valid assessment of clinical outcome could not be made (e.g., participant did not attend end of therapy visit, or extenuating circumstances or lost to follow-up). Participant with missing responses were categorized as 'Missing'. Follow up visit (Day 22 to 28)
Secondary Number of Participants With Protocol-defined Diarrhea (PDD) (Due to Study Medication) Protocol-defined diarrhea was defined as a) 3 or more watery stools in one day or b) 4 or more loose/watery stools in one day or c) 2 watery stools per day for two consecutive days or d) 3 loose/watery stools per day for two consecutive days. From OT visit (Day 3 to 5) to FU visit (Day 22-28)
See also
  Status Clinical Trial Phase
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04537663 - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults Phase 4
Terminated NCT04583280 - A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV) Phase 3
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Active, not recruiting NCT03251196 - TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
Completed NCT02561871 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers Phase 1
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Terminated NCT02032056 - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period N/A
Completed NCT01419262 - DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers Phase 3
Terminated NCT01432080 - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant Phase 2
Completed NCT00984945 - Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults Phase 1
Completed NCT00127686 - Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep Phase 1
Active, not recruiting NCT01107223 - Long Term Effect of General Practitioner Education on Antibiotic Prescribing N/A
Completed NCT03739112 - Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly Phase 3
Completed NCT04144491 - Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda N/A
Completed NCT05318235 - Virus Interactions in the Respiratory Tract; a Cohort Study With Children
Active, not recruiting NCT04170348 - Daily Vitamin D for Sickle-cell Respiratory Complications Phase 2
Completed NCT04525040 - ProbioKid as Prevention Among Kids With Frequent URTI N/A
Completed NCT05535777 - Patient Portal Flu Vaccine Reminders_RCT 5 (LADHS) N/A
Not yet recruiting NCT05914324 - Outpatient Pediatric Pulse Oximeters in Africa N/A