Use of Oral Prednisone in Acute Sore throats

Use of oral prednisone in the treatment of acute sore throat - a randomised control trial

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000017224

Acronym

OPfAST

Enrollment

Registered

2018-01-11

Start date

2018-02-01

Completion date

2019-07-05

Last updated

2019-09-16

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

Conditions

None listed

Brief summary

This is a novel study to investigate the use of oral prednisone for the treatment of acute sore throat. There have been previous studies conducted that looked at steroid in the context of tonsillitis and acute pharyngitis in the past by Kiderman et. al. (2005) and Crawford-Faucher (2014). However all previous published work had patients being given concurrent antibiotics with the steroids. We propose to perform a randomised controlled trial comparing oral prednisone to placebo where the antibiotics are withheld. Safeguards for strep throat infections will be taken in the form of throat swabbing of all our participants and where necessary, delayed antibiotics prescribed.

Interventions

Oral Prednisone in the treatment of Acute sore throat 40mg of prednisone administered daily for 2 days against placebo tablets taken for the same period of time. Patients will be contacted at 48 hours for symptomatic scoring and be asked to return and pain diary that will be provided to them All patients will be swab to rule out Group A strep infection and when throat swabs are noted to be positive generally after 48 hours, these patients would be treated appropriately with antibiotics.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age 16 and older with sore throat occurring within the last 7 days. If they are having and have had a sore throat within the last 7 days at the time of enrolment

Exclusion criteria

1. Patients allergic to oral prednisone 2. Patients deemed by the examining clinician to require immediate oral antibiotics due to high suspicion of Group A Streptococcal infection based on the modified Centor/McIssac criteria (9). 3. Female participants who are pregnant or lactating 4. Participant who are at the time of assessment currently taking or in the last 14 day been administered antibiotics or steroids orally or intravenously or on long term inhaled steroids 5. Participants who are immunodeficient or immunocompromised (HIV, current chemotherapy, active malignancy), are due to have elective surgery with general anaesthesia in the following 7 days, terminally ill and those that have signs or symptoms that would require hospitalisation such as peri tonsillar abscess, unable to swallow, systemically unwell. 6. Patients with unstable diabetes or a venous or arterial ulcer on their leg.

Outcome results