Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

Combined Military Hospital, Pakistan

Status: Completed

Conditions: Tonsillitis Streptococcal

Treatments: Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT04215770

CMH-01-2019

Details and patient eligibility

About

To compare intravenous Co-amoxiclav versus Benzyl penicillin in children with severe streptococcal tonsillitis in terms of efficacy, safety and cost effectiveness.

Full description

Efficacy was measured through improvement (decrease in fever, settling lymphadenopathy and disappearance of tonsillar exudate) in Centor Criteria score on daily basis. Improvement i.e reduction in Centor Criteria score was recorded for all children till full recovery.

Safety was measured by frequency of hypersensitivity reactions or severe side effects of antibiotics necessitating stoppage of the drug. All the children in both Groups were given test dose of the antibiotic before giving full dose of antibiotic prescribed.

Cost effectiveness was compared in terms of total cost of injections (Co-amoxiclav versus Benzyl penicillin) which were administered to children in both groups.

Enrollment: 310 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children who had 3 or 4 score according to Centor Criteria for tonsillitis/pharyngotonsillitis, were included in study
2. Children between ages of 5 to 15 years
3. Children with positive Rapid Antigen detection Test (RADT) for Streptococcus Pyogenes

Exclusion criteria

1. Immunocompromised children
2. Children with known hypersensitivity to Penicillins (esp Coamoxiclav and Benzyl penicillin)
3. Children with liver or renal failure
4. Children who were already using any oral or parenteral antibiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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310 participants in 2 patient groups

Inj Co-amoxiclav

Active Comparator group

Description:

Group A children were advised Inj Co-amoxiclav 50 units/kg/day in 3 divided doses daily

Treatment:

Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day

Inj Benzyl Penicillin

Active Comparator group

Description:

Group B patients were advised inj Benzyl Penicillin 25000 units/kg/day in 3 divided doses

Treatment:

Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day