| CTRI Number |
CTRI/2025/02/081358 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Antibiotic (Amoxicillin and Clavulanic Acid) in Children with Acute Respiratory Tract Infections |
|
Scientific Title of Study
|
A Phase 4 Multicentric Open Label Clinical Study to Evaluate the Clinical Safety and Efficacy of
Amoxicillin and Clavulanic Acid in Children with Acute Respiratory Tract Infections |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MC/CLV/23-004 Version 1.1 05/Jan/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhilesh Sharma |
| Designation |
President & Chief Medical Officer |
| Affiliation |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel,
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02239829999 |
| Fax |
|
| Email |
akhilesh.sharma@alkem.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dattatray Pawar |
| Designation |
Deputy General Manager |
| Affiliation |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel,
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02239829999 |
| Fax |
|
| Email |
dattatray.pawar@alkem.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mukesh Jaiswal |
| Designation |
Project Manager |
| Affiliation |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel,
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02239829999 |
| Fax |
|
| Email |
mukesh.jaiswal@alkem.com |
|
|
Source of Monetary or Material Support
|
| Alkem Laboratories
Alkem House, Senapati Bapat Marg,
Lower Parel,
Mumbai – 400013 |
|
|
Primary Sponsor
|
| Name |
Alkem Laboratories Limited |
| Address |
Alkem Health Sciences,
A Unit of Alkem Laboratories Limited,
Unit-2, Samardung, Karek Block, Namthang,
Sikkim Namthang - 737137 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukesh Sanklecha |
Bombay Hospital & Medical Research Centre |
Department of Paediatrics, Consulting room - 2nd Floor, New Wing,
12, Vitthaldas Thackersey Marg, near Liberty cinema, New Marine Lines, Marine Lines, Mumbai, Maharashtra 400020
Mumbai
MAHARASHTRA |
9869134900
doctormukesh@gmail.com |
| Dr MMA Faridi |
Eras Lucknow Medical College and Hospital |
Department of Pediatrics, Eras Lucknow Medical College and
Hospital, Sarfarazganj, Hardoi Road,
Lucknow-226003
Lucknow
UTTAR PRADESH |
7317794765
mmafaridi@yahoo.co.in |
| Dr Janani Sankar |
Kanchi Kamakoti CHILDS Trust Hospital |
KKCTH outpatient department
1st floor, Room No. 124,
12 A, Nageswara Rd, Tirumurthy Nagar, Nungambakkam, Chennai, Tamil Nadu 600034
Chennai
TAMIL NADU |
9841078101
janani.sankar@yahoo.com |
| Dr Kalpana Dutta |
Medical College and Hospital |
HDU Building, 3rd Floor, Department of Paediatrics, 88, College St, Calcutta Medical College, College Square, Kolkata, West Bengal 700073
Kolkata
WEST BENGAL |
9836424144
drkalpanadatta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| BOMBAY HOSPITAL ETHICS COMMITTEE |
Submittted/Under Review |
| Ethics Committee of KKCTH and CTMRF |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Submittted/Under Review |
| Institutional Ethics Committee, Eras Lucknow Medical College Hospital |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amoxicillin and Clavulanate Potassium for Oral Suspension (600 mg+42.9 mg) per 5 ml as per body weight |
Drug: Amoxicillin and Potassium Clavulanate 600/42.9mg / 5ml
Route/mode of administration: Reconstitution into Oral Suspension. Oral suspension will be administered according to weight of the enrolled patient
Dose: Amoxicillin/clavulanate 90/6.4 mg/kg/day
Dosage schedule: Once every 12 hours (Twice Daily)
Duration of treatment: Treatment should be given for 10-14 days as per investigators judgement. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender, aged between greater than equal to 6 months and less than 18 years.
2. Clinical diagnosis of Acute Respiratory Tract Infections [Upper Respiratory Tract
Infections (AOM, tonsillopharyngitis, or sinusitis) or Lower Respiratory Tract Infections
(lobar and bronchopneumonia)]
i) Diagnosis of AOM confirmed if any of the following is present
a)Purulent otorrhea for less than than 24 hours
b)Middle ear effusion (MEE) diagnosed based on the presence of at least two of the following otoscopic findings
A) decreased/absent tympanic mobility,
B) yellow/white discoloration of the tympanic membrane,
C) opacification of the tympanic membrane,
D) acute inflammation at least any one: ear pain within 24 hours with tugging/rubbing of ear, marked redness of the tympanic membrane, distinct
fullness/bulging of the tympanic membrane
ii) Diagnosis of tonsillopharyngitis confirmed based on
a) Sore throat associated with erythema and/or pharyngeal/tonsillar exudate with or without scarlatiniform rash
b) Presence or absence of fever and/or general malaise
iii) Diagnosis of sinusitis confirmed based on the following
a) Inflammation of nasal mucosa,
b) Purulent/mucopurulent nasal or postnasal discharge
c) Total score of the following symptoms ≥4 (suggestive of moderate or severe
ABRS)
A) rhinorrhea (none 0, mild/small amount 1, moderate or severe 2);
B) bad mood/productive cough (none 0, mild/small amount 1, moderate or severe: 2);
C) nasal/postnasal discharge [none 0 (serous), mild/small amount 1
(mucopurulent, small amount), moderate or severe: 2 (moderate or larger amount)]
iv) Diagnosis of lobar and bronchopneumonia confirmed if microbiology-based confirmatory tests are available and if at least three of the following criteria are present
a) History of fever (oral temperature greater than 38°C or axillary temperature greater than 37.5°C) or hypothermia (oral temperature less than 35°C or axillary temperature less than 34.5°C)
b) Acute onset or worsening of at least two of the following within past 3 days of enrolment
A) cough,
B) respiratory distress
C) tachycardia (greater than 6 months to less than 24 months: greater than 160 beats/min; greater than 24 months to less than 10 years greater than 140 beats/min; greater than 10 years greater than 100 beats/min) (if available in clinical and medical records)
D) tachypnea (greater than 6 months to less than 12 months: greater than 50 breaths/min; greater than 12 months to less than 5 years greater than 40 breaths/min; greater than 5 years greater than 20 breaths/min) (if available in clinical and medical records)
c) Presence of infiltrates including new alveolar or lobal infiltrate or consolidation as visible on imaging (if available in clinical and medical records)
3. Not requiring hospitalization based on the investigators opinion.
4. Ineffective antimicrobial response within 72 hours of initial treatment (except for AOM).
5. Participants LAR willing to provide informed consent for study participation |
|
| ExclusionCriteria |
| Details |
1. History of or pre-existing renal insufficiency, hepatic dysfunction, or immunodeficiency
2. Congenital disorders such as maxillofacial dysplasia or Down’s syndrome
3. Spontaneous perforation of the tympanic membrane and drainage for longer than 24 hours
4. Tympanoplastic tube(s) in place, or has anatomic abnormalities associated with recurrent
AOM, prolonged MEE, including cleft palate or repair, high-arched palate
5. ABRS patient with surgical history (patient with a pervious surgery is greater than equal to 365 days before and apparently preserved maxillary sinus mucosa or patient with a previous surgery of nasal polypectomy is greater than equal to 90 days before may be considered)
6. Severe cases of CABP including hypoxemic, septic, ventilator-associated or hospital acquired
pneumonia
7. Evidence of infectious mononucleosis, leukopenia and/or thrombocytopenia, or diarrhoea at the time of screening
8. Receiving or has received more than one dose of systemic antibiotic or medication affecting bowel movement at the time of enrolment
9. Any condition or concomitant medication, that in the opinion of the investigator, might
affect study outcome
10. Any condition in the patient, that in the opinion of the investigator, might worsen upon
participation in the study
11. Known allergy or hypersensitivity to the components of the study medication
12. Participation in another clinical trial within past 30 days |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of participants with adverse events (AE) and serious adverse events
(SAEs) [From start of treatment (Day 1) to follow-up visit at Day 28] (AEs and
SAEs will be collected). |
Day 1, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients with primary clinical response. [From start of treatment (Day 1) to end of therapy visit at Day 12-14] At the end of therapy (EOT) visit (Days 12 to 14),the primary clinical response will be evaluated in terms of the study interventions effectiveness or failure. A clinical cure or improvement will be considered a treatment success at EOT. A participant whose clinical outcome is clinical failure (owing to worsening or non-improvement in symptoms) or unable to determine is considered to have failed the treatment.
|
Day 1, Day 14, Day 28 |
Proportion of patients with secondary clinical response [From end of treatment visit (Day 12-14) to follow up visit at Day 22-28]. At follow-up (Days 22 to 28), secondary clinical response will be evaluated in terms of the success or failure of the study intervention. Treatment failure will be clinical recurrence or inability to determine, while treatment success will be lasting clinical cure.
|
Day 14, Day 28 |
| Time to clinical response evaluated using disease specific subject diary card. |
Day 1, Day 14, Day 28 |
| Incidence of protocol defined diarrhoea (PDD) (due to study medication) [From start of treatment (Day 1) to end of therapy visit at Day 12-14] The protocol defines diarrhoea as having three or more watery stools in a single day, four or more loose/watery stools in a single day, two watery stools in a row, or three loose/watery stools in a row. |
Day 1, Day 14 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a prospective, interventional, open-label, non-comparative, multicentric study using a comparative enrolment of participants from 4 sites throughout India. The test drug is amoxicillin and Potassium Clavulanate 600/42.9 mg (14:1) per 5 ml powder for reconstitution into Oral Suspension which will be administered orally once every 12 hours depending on the dose prescribed. There are three visits in the study (Visit 1,Visit 2 and Visit 3). Visit1 (Day 1) is screening visit where subject will be screened as per study inclusion and exclusion criteria’s. Eligible subject will be enrolled into the study and IP will will be dispensed on same day. IP will prescribed as per prescribing instruction mentioned in study protocol and a dairy card will dispensed to the subject to record their symptoms on daily basis. Subject will revisit the site on V2 (Day 14) and symptoms will be checked, IP compliance will be verified and diary card will be reviewed by Investigator. CBC will be performed at V1 and V2 for safety purpose. Subject will revisit the site on V3 (Day 28) for End of study visit. PI will check the recurrence of symptoms status during this visit. |