A Phase IV Study to Evaluate the Safety and Efficacy of Augmentin Extra Strength (ES)-600 (amoxicillin/potassium clavulanate 14:1 combination) in Children with Acute Respiratory Tract Infections (ARTIs) in India

Phase 4

Completed

• Conditions: Health Condition 1: J00-J99- Diseases of the respiratory system

• Registration Number: CTRI/2021/12/038933
• Lead Sponsor: GlaxoSmithKline Research Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-11-12
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 310

Inclusion Criteria

Diagnosis of AOM on basis of otoscopic findings as defined below

Purulent otorrhea of less than 24 hours duration

OR Middle ear effusion (MEE)

Middle ear effusion is evidenced by at least two of the following:

Decreased or absent tympanic mobility measured by pneumatic otoscopy,

Yellow or white discoloration of the tympanic membrane, or Opacification of the tympanic membrane PLUS At least one of the following indicators of acute inflammation: Ear pain within 24 hours, including unaccustomed tugging or rubbing of ear, Marked redness of the tympanic membrane, or Distinct fullness or bulging of the tympanic membrane.

OR Child with ABRS with inflammation as bacterial infection who has the following symptoms/signs on the day of or the day before the first dose of the investigational product:

Redness of the nasal mucosa.

Nasal or postnasal discharge is purulent or mucopurulent. Pathological shadow in the paranasal sinus on a radiogram (only for reference-based on investigator discretion). Patient with surgical history should be excluded but patient with a pervious surgery more than 365 days before and apparently preserved maxillary sinus mucosa or patient with a previous surgery of nasal polypectomy more than 90 days before may be enrolled in the study.

Child with ABRS whose severity is classified as moderate or severe (total score greater than or equal to 4) based on the nasal cavity findings and symptoms as shown below.

Symptom: Rhinorrhoea- None: 0 Mild/Small amount : 1 Moderate or severe: 2

Symptom: Bad mood/ productive cough- None: 0 Mild/Small amount : 1 Moderate or severe: 2

Nasal cavity finding: Nasal/postnasal discharge- None: 0 (Serous) Mild/small amount: 2 (Mucopurulent, small amount) Moderate or

severe: 4 (Moderate or larger amount)

OR Child diagnosed with CABP based on following criteria: (At least three of the four criteria should be met to include in the study)

i. History of documented fever (rectal, ear, or oral temperature >=38°C or axillary temperature >=37.5°C) or hypothermia (rectal, ear, or oral

temperature <35°C or axillary temperature <34.5°C)

ii. Acute onset or worsening within the previous 5 days of at least two of the

following nine clinical signs and symptoms:

•cough,

•tachycardia, defined as follows:

â?ª6 months to <24 months: >=160 beats/min

â?ª24 months to <10 years: >=140 beats/min

â?ª>=10 years: >=100 beats/min

•tachypnea, defined as follows:

â?ª6 months to <12 months: >=50 breaths/min

â?ª12 months to <5 years: >=40 breaths/min

â?ª>=5 years: >=20 breaths/min

•dyspnea,

•grunting,

•sputum production,

•chest pain,

•cyanosis,

•increased work of breathing

iii. At least one of the five following laboratory findings:

•leukocytosis ( >15,000 white blood cells/mm3

)

• >15% immature neutrophils (bands) regardless of total peripheral

white blood cell (WBC),

•leukopenia (4,500 WBC/mm3

)and

iv. Presence with new infiltrates consistent with bacterial pneumonia including new alveolar or lobal infiltrate or consolidation (based on imaging result) - based on investigatorâ??s discretion only

3. The participant and parent(s)/legal guardian(s) are willing and able to comply

with

Exclusion Criteria

Participants will be excluded from the study if they meet any of the following exclusion

criteria:

1. Weight >= 40 kg

2. Pre-existing renal insufficiency (eg, plasma creatinine >1.5 times upper limit of

normal range for age)

3. Pre-existing liver disease(s) and/or hepatic dysfunction

4. A serious underlying disease as per clinicianâ??s judgment.

5. Currently having diarrhea at the time of screening

6. Concomitant infection which would preclude evaluation of the response to study

intervention.

7. Concomitant condition precluding evaluation of clinical response (such as acute

mastoiditis, facial palsy, bacterial meningitis, and brain tumor) that would

preclude evaluation of the response to study intervention.

8. Congenital disorders such as maxillofacial dysplasia.

9. Spontaneous perforation of the tympanic membrane and drainage for longer than

24 hours.

10. 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 Downâ??s syndrome.

11. Severe cases of CABP including Hypoxemic, Septic, Ventilator-associated or

hospital-acquired pneumonia

12. Need corticosteroid for systemic (inhalational steroids as controller therapy in

asthma is allowed)

13. Infectious mononucleosis

14. Evidence of leukopenia and/or thrombocytopenia.

15. History of previous hypersensitivity reaction to penicillins, cephalosporins or

other Beta-lactam antibiotics.

16. History of AMC/CVA-associated cholestatic jaundice/hepatic dysfunction.

17. History of phenylketonuria or a known hypersensitivity to aspartame.

18. Received, within 48 hours of study entry, or is scheduled to receive during the

study period, any medication which may alter bowel function.

19. Currently receiving or has received more than one dose of systemic antibiotic

therapy within one week prior to the initiation of the study.

20. Receipt of an investigational compound (non-FDA and non-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.

21. Participants with symptoms suggestive of active COVID-19 infection (ie, fever,

cough, etc).

22. Participants with known COVID-19 positive contacts within the past 14 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified