NCT03331497

Brief Summary

Children with periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) -syndrome diagnosis will be randomised either to tonsillotomy (partial tonsillectomy) or 3 months follow up. At follow up visit 3 months after randomisation the children from either groups with ongoing symptoms will be sent to tonsillectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

4.2 years

First QC Date

October 31, 2017

Last Update Submit

February 3, 2022

Conditions

PFAPA Syndrome

Outcome Measures

Primary Outcomes (1)

  • Cure

    Proportion of patients who do not have any PFAPA symptoms

    3 months from randomization

Secondary Outcomes (3)

  • Rescue surgery

    12 months from randomization

  • Days with fever

    3 months from randomization

  • Cure

    6 months from randomization

Study Arms (2)

Tonsillotomy

EXPERIMENTAL

The patients diagnosed with PFAPA will have tonsillotomy performed in one month from randomisation.

Procedure: Tonsillotomy

Follow up

NO INTERVENTION

The patients diagnosed with PFAPA will be monitored for 3 months time. If the symptoms still persist, tonsillectomy will be performed

Interventions

TonsillotomyPROCEDURE

About 2/3 of the palatine tonsil tissue is removed with coplator or bipolar knife.

Tonsillotomy

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed PFAPA syndrome: regularly occurring fever episodes for 3-5 days for at least five times or for 6 months

You may not qualify if:

  • prior tonsil surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Oulu Unversity Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Marshall syndrome

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 6, 2017

Study Start

October 24, 2017

Primary Completion

December 30, 2021

Study Completion

February 2, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02

Locations

FI(3)