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A Real World Evidence study to understand the effectiveness and tolerability of different combination of antibiotics on patients with pharyngitis

Effectiveness and Tolerability of Cephalexin and Clavulanic Acid Fixed Dose Combination, Amoxicillin and Clavulanic Acid Fixed Dose Combination, and Azithromycin in Patients with PHARYngitis in India: A Real-World RetroSPective Study from ElectrOnic Medical Records (PHARYSPOR) - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/08/056474
Enrollment
750
Registered
2023-08-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J020- Streptococcal pharyngitis

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Sun Pharmaceutical Industries Limited (SPIL)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients aged more than or equal to 18 years of either gender 2. Patients with signs and symptoms of pharyngitis suggestive of bacteriological etiology, alone or in combination (fever, sore throat, throat pain/difficulty in swallowing, inflammation of tonsils) at the initiation of treatment 3. Patients prescribed with oral cephalexin and clavulanic acid combination or other commonly prescribed antibiotics (Amoxicillin + clavulanic acid or Azithromycin) for the management of pharyngitis

Exclusion criteria

Exclusion criteria: 1. Patients with incomplete medical records with respect to the required study parameters 2. Patients requiring hospitalization or parenteral antibiotic treatment 3. Patients with history of allergy or contraindications to study medications

Design outcomes

Primary

MeasureTime frame
Proportion of patients achieving clinical cure from baseline till 10 days from treatment initiation (Clinical cure is defined as complete resolution of infection-related clinical signs & symptoms)Timepoint: From baseline till 10days

Secondary

MeasureTime frame
1. Proportion of patients achieving clinical improvement on Day 2, 3, 5, & 7 from treatment initiation (Clinical improvement is defined as partial resolution of infection-related clinical signs & symptoms) 2. Time to clinical improvement 3. Proportion of patients requiring addition of NSAID 4. Proportion of patients requiring addition/change in antibiotics 5. Proportion of patients with adverse eventsTimepoint: Day 2, 3, 5, 7 & 10 days

Countries

India

Contacts

Public ContactDr Chintan Khandhedia

Sun Pharmaceutical Industries Limited

archana.Karadkhele@sunpharma.com02243244324

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jul 11, 2026