| CTRI Number |
CTRI/2025/12/099654 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study in Patients with Bacterial Infections to Compare the Effectiveness and Safety of Two Amoxicillin- Tablets |
|
Scientific Title of Study
|
A Randomized, Open label, Multicentre, Parallel group, Active-Controlled Comparative Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of Amoxycillin and Potassium Clavulanate Oral Dispersible Tablet (600 mg/42.9 mg) for the Treatment of Bacterial infections Compared to Amoxycillin 400mg Dispersible Tablet in Indian Patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VRL-CT-25-022, version no. 1.0 dated 15.05.2005 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avinash Andhale |
| Designation |
Principal Investigator |
| Affiliation |
Vivotech Research Private Limited |
| Address |
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Thane
MAHARASHTRA
400703
India |
| Phone |
9987598349 |
| Fax |
|
| Email |
pi@vivotechresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash Andhale |
| Designation |
Principal Investigator |
| Affiliation |
Vivotech Research Private Limited |
| Address |
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Thane
MAHARASHTRA
400703
India |
| Phone |
9987598349 |
| Fax |
|
| Email |
pi@vivotechresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamlesh Londhe |
| Designation |
Director |
| Affiliation |
Vivotech Research Private Limited |
| Address |
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Thane
MAHARASHTRA
400703
India |
| Phone |
7738530479 |
| Fax |
|
| Email |
kamlesh@vivotechresearch.com |
|
|
Source of Monetary or Material Support
|
| MALIK LIFE SCIENCES PVT. LTD. 131 to 133, Block –C, Mangolpuri Ind. Area, Phase – 1, (adjoining CBSE office ) Delhi - 110083 |
|
|
Primary Sponsor
|
| Name |
MALIK LIFE SCIENCES PVT. LTD. |
| Address |
131 to 133, Block –C, Mangolpuri Ind. Area, Phase – 1, (adjoining CBSE office ) Delhi - 110083 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Malik Life Sciences Pvt Ltd |
PLOT No. 16, Vardhman Industrial Estate, Village Bahadarpur Saini, N. H. 58, Haridwar - 247667, Uttarakhand |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jigar Piyush Modia |
Jupiter Hospital & Research Centre |
Clinical Research Dept.,
Opp. ICAI Bhavan Sun Pharma-Atladara road, Atladara, Vadodara -390012
Vadodara
GUJARAT |
9913041639
drjigarmodianm@gmail.com |
| Dr Ravi D |
Mandya Institution of Medical Sciences, |
Clinical Research Dept, 02nd Floor, Mandya MC Road Nehrunagar Mandya Karnataka-571401
Mandya
KARNATAKA |
9972254142
dravi2k@rediffmail.com |
| Dr C Prashanth |
Mysore Medical College & Research Institute |
Princess Krishnajammanni TB & Chest dept, Tuberculosis and chest disease hospital, 1st cross rd, Brindavan Extension 1st stage, Mysuru, Karnataka- 570015
Mysore
KARNATAKA |
8032481846
prshnthcr@gmail.com |
| Dr Karishma Ramesh Manwani |
Parikh Multispeciality Health Care Pvt. Ltd. |
A/4, Trial Department, Bhagwati Park, Opp. Tube company, Near Gajanan Complex, Old Padra road, Vadodara, Gujarat -390020
Vadodara
GUJARAT |
9925529932
karishma.manwaninm@gmail.com |
| Dr Rajkumar Gautam Nikalje |
Punawale Multispeciality Hospital |
Dept of Respiratory, Punawale Ravet Road, Near Khandoba Mandir, Behind Cyprus Society, Pune - 411033
Pune
MAHARASHTRA |
7378306651
rajukmar.nikalje23@gmail.com |
| Dr Sanjay Kumar |
The Medicity Hospital |
Dept of Medicine, Teen Patti road Rudrapur Udham Singh Nagar Uttarakhand 263153
|
9868080947
drsanjaymamc0078@zoho.com |
| Dr Ritu Gupta |
Uttar Pradesh University of Medical Sciences |
Department of ENT, Saifai Etawah, India- 206130
Etawah
UTTAR PRADESH |
759900525
rituguptasaraf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee Mysore Medical College and Associated Hospital |
Submittted/Under Review |
| IEC UTTAR PRADESH University of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, Mandya Institute of Medical Sciences |
Submittted/Under Review |
| Jupiter Hospital & Research Centre Institutional Ethics Committee |
Approved |
| Parikh Institutional Ethics Committee |
Approved |
| Skinovate Independent Ethics Committee |
Approved |
| V3 Healthcare Private Limitedh Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amoxycillin
and Potassium Clavulanate Oral Dispersible Tablet (600 mg/42.9 mg) |
one tablet twice a day orally, swallowed with water or without water for 7-10 days |
| Comparator Agent |
Amoxycillin 400mg Dispersible Tablet |
One tablet twice a day orally, swallowed with
water for 7-10 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects meeting the following criteria will be included in the study.
1. Male or female patients aged eighteen to sixty five years.
2. Clinical diagnosis of one or more of the following conditions.
a. Acute Otitis Media.
b. Acute Bacterial Sinusitis.
c. Acute Tonsillopharyngitis.
d. Lobar pneumonia or bronchopneumonia of mild to moderate severity.
3. Acute onset of symptoms within the last three to seven days.
4. Presence of at least one systemic sign of infection, such as fever of thirty eight degrees Celsius or higher, purulent ear discharge, purulent nasal discharge, purulent pharyngeal discharge, or leukocytosis, if available.
5. Patients not requiring hospitalization or intravenous antibiotic therapy.
6. Willing and able to provide written informed consent.
7. Willing to adhere to the study protocol and attend all scheduled study visits. |
|
| ExclusionCriteria |
| Details |
Subjects will be excluded from the study for any of the following reasons.
1. Known or suspected hypersensitivity to penicillins, clavulanate, or other beta lactam antibiotics.
2. History of cholestatic jaundice or hepatic dysfunction associated with previous amoxicillin clavulanate therapy.
3. Evidence of moderate to severe renal impairment, defined as an estimated glomerular filtration rate less than sixty milliliters per minute per one point seven three square meters.
4. Suspected or confirmed infectious mononucleosis.
5. Current or recent use of systemic antibiotics or drugs that affect bowel motility within the last seventy two hours.
6. Immunocompromised state, including the following.
a. Active chemotherapy or radiotherapy.
b. Long term corticosteroid use.
c. CD four count less than two hundred in human immunodeficiency virus positive patients.
7. Pregnant or lactating women.
8. Known history of peptic ulcers, inflammatory bowel disease, or antibiotic associated colitis.
9. Any condition, including chronic diseases or concomitant medications, that in the opinion of the investigator may interfere with study conduct or interpretation of results, or may pose a risk to subject safety.
10. Participation in another clinical trial within the last thirty days.
11. Severe pneumonia, defined as the presence of respiratory failure, hypoxemia requiring oxygen therapy, or suspected or confirmed sepsis.
12. Presence of gastrointestinal symptoms at screening, such as vomiting or severe diarrhea, that may interfere with drug absorption. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective of this study is to evaluate the clinical efficacy of Amoxycillin
and Potassium Clavulanate Oral Dispersible Tablet (600 mg/42.9 mg) as compared to
Amoxycillin 400 mg Dispersible Tablet in adult patients with acute bacterial infection from Day 1–10 |
The primary objective of this study is to evaluate the clinical efficacy of Amoxycillin
and Potassium Clavulanate Oral Dispersible Tablet (600 mg/42.9 mg) as compared to
Amoxycillin 400 mg Dispersible Tablet in adult patients with acute bacterial infections from Day 7–10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To evaluate the time to resolution of key infection-related symptoms.
• To assess the safety & tolerability of the investigational & comparator products.
• To determine the microbiological eradication rate (where culture data is available).
• To assess treatment compliance based on dosing records.
• To evaluate patient acceptability & ease of administration of the dispersible tablet
formulation. |
Number of days from the first dose of study drug to complete resolution of key
symptoms i.e. from Day 1 to Day 7-10 |
|
|
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 3 |
|
Date of First Enrollment (India)
|
03/01/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a randomized, open-label, multicentre, parallel-group, active-controlled Phase 3 trial to be conducted across multiple sites in India after obtaining regulatory and Ethics Committee approvals. Following informed consent, patients will undergo screening (up to 3 days), and the total study duration will be 14 days. Eligible patients will be randomized 1:1 to receive either amoxicillin–clavulanate or amoxicillin alone for 7–10 days. The study includes four visits: screening, baseline/enrolment, end of treatment, and follow-up. Non-responders will continue treatment with add-on therapy; their safety data will be included in safety and ITT analyses, though their efficacy data will be excluded from the primary efficacy analysis. Safety and efficacy assessments will be conducted throughout the study as per the schedule of assessments. |