CellulitisPhase 4PEDOCELLNCT02922686
Penicillin for the Emergency Department Outpatient Treatment of CELLulitis
A Phase 4 study testing Flucloxacillin and Phenoxymethylpenicillin in people with Cellulitis and Wound Infection, run by Royal College of Surgeons, Ireland at 5 sites in Ireland.
Trial summary
The main objective of this study is to investigate the non-inferiority of oral flucloxacillin alone compared with a combination of oral flucloxacillin and phenoxymethylpenicillin for the emergency department directed outpatient treatment of cellulitis, wound infections and abscesses, recently renamed by the Food and… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cellulitis, Wound Infection, Abscess
- What is being tested?
- Flucloxacillin and Phenoxymethylpenicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 414 participants
- Where
- 5 sitesIreland
- Study dates
- Dec 2016to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinically diagnosed cellulitis, wound infections or abscess (ABSSSI) affecting any body part, excluding the perineum, and having any two of the following signs:
- Erythema
- Warmth
- Tenderness / Pain of affected area
- Oedema / Induration
- Regional lymphadenopathy
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- Cellulitis, wound infection and abscess deemed treatable with oral outpatient antibiotics in which either combination of antibiotic is likely to produce a clinical response (Eron Class 1-2)
- Written informed consent obtained.
- 16 years of age or older.
- Fluency in written and spoken English.
- Willing to return for study follow-up or to have the research nurse visit their home.
- Willing to receive a telephone call from a study investigator.
Who cannot join
- Penicillin allergy (self-reported or confirmed).
- Any cellulitis, wound infection and abscess that treating clinicians deem treatable with intravenous (IV) antibiotics.
- Any cellulitis, wound infection and abscess that is more severe than Eron Class 2 (Appendix 2)
- Any cellulitis, wound infection and abscess of the perineal region.
- Patients who have received more than 24 hours of effective antibiotics for the current episode of acute cellulitis, wound infection or abscess
- Any medical condition, based on clinical judgment, that may interfere with interpretation of the primary outcome measures (e.g. chronic skin condition at the lesion site)
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- Immunodeficiency from primary or secondary causes (e.g. corticosteroids, chemotherapeutic agents).
- Previous history of renal dysfunction or known chronic kidney disease under care of a nephrologist. - Previous history of liver dysfunction defined as chronically deranged liver function tests elicited from medical notes or history.
- Suspected or confirmed septic arthritis.
- Suspected or confirmed osteomyelitis.
- Infection involving prosthetic material.
- Pregnant or lactating women.
- Patients with a previous history of flucloxacillin- associated jaundice/hepatic dysfunction
- Patients with a previous history of MRSA colonization/infection.
- Patients with lactose intolerance diagnosed by a medical professional
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Ireland5 sites
Department of Emergency Medicine, Connolly Hospital,
Blanchardstown, Dublin, Dublin 15
Joseph McKeever, joseph.mckeever@hse.ie
Department of Emergency Medicine, Mercy University Cork
Cork, Greenville Place, Cork
Chris Luke
Department of Emergency Medicine, Cork University Hospital
Cork, Wilton, Cork
Conor Deasy, conor.deasy@hse.ie
Department of Emergency Medicine, Mater Misericordiae University Hospital
Dublin, Dublin, Dublin 7
Adrian Moughty, amoughty@mater.ie
Michael Quirke
Beaumont Hospital,
Dublin, Dublin, Dublin 9
Abel Wakai, MD FRCEM, awakai@rcsi.ie
Michael Quirke, michaelquirke@rcsi.ie
About this study
Official title: Oral Flucloxacillin Alone Versus Flucloxacillin and Phenoxymethylpenicillin for the Emergency Department Outpatient Treatment of Cellulitis: a Non-inferiority Randomised Controlled Trial.
The main objective of this study is to investigate the non-inferiority of oral flucloxacillin alone compared with a combination of oral flucloxacillin and phenoxymethylpenicillin for the emergency department directed outpatient treatment of cellulitis, wound infections and abscesses, recently renamed by the Food and Drug Administration (FDA) as acute bacterial skin and skin structure infections (ABSSSIs). Half of the trial participants will receive flucloxacillin and placebo in combination, and the remaining half will be treated will flucloxacillin and phenoxymethylpenicillin.
In a secondary objective the trial aims to measure adherence and persistence of trial patients with outpatient antibiotic therapy. In addition a within-trial evaluation of the cost per quality adjusted life year (QALY) gained from the use of oral flucloxacillin compared with combination therapy from the perspective of the health-care payer (direct costs) the patient and government. Finally the study will externally validate the Extremity Soft Tissue Infection-score, a Health Related Quality of Life (HRQL) questionnaire designed to quantify the impact of cellulitis, wound infections and abscesses on patient HRQL in clinical trials.
Read the detailed description
There is obvious clinical equipoise between the use of oral flucloxacillin alone or combined with phenoxymethylpenicillin for the emergency department treatment of cellulitis, wound infections and abscesses as evidenced by current disparate prescribing practice and hospital guidelines. Feasibility studies for the planned trial have shown that 45-50% of emergency department patients with these infections in Ireland are discharged on oral antibiotics which is consistent with findings in other jurisdictions. Despite the significant healthcare and economic costs associated with cellulitis, there is a paucity of scientific evidence concerning the appropriate antibiotic treatment for these conditions. Additionally, "less severe" infections tend to be over-treated and severe infections under-treated, indicating unjustifiable levels of antibiotic misuse, insufficient knowledge of therapeutics and a lack of evidence to risk-stratify patients with cellulitis to different treatments.The planned trial is therefore likely to be definitive due to the current clinical equipoise between the use of both penicillins for the emergency department outpatient treatment of this group of infections
- Conditions
- Cellulitis, Wound Infection, Abscess
- Being tested
- Flucloxacillin, Phenoxymethylpenicillin, Placebo (for phenoxymethylpenicillin)
- Medical subject headings
- Cellulitis, Wound Infection, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlucloxacillinDrug
Also called Floxapen, 500 mg Capsules,, Marketing Authorisation Number PA1380/011/002
One flucloxacillin capsule of 500mg strength taken four times daily for 7 days
PhenoxymethylpenicillinDrug
Also called Marketing Authorisation Number PL; 04520/0005
One capsule of phenoxymethylpenicillin of 500 mg strength taken four times daily for 7 days
Placebo (for phenoxymethylpenicillin)Drug
Also called Over-encapsulated investigative medicinal product.
Over-encapsulation of phenoxymethylpenicillin will be performed by the manufacturer of the investigational medicinal products such that placebo and active phenoxymethylpenicillin are identical in size, shape, colour and smell, and are packaged in identical bottles
| Study group | Role | What they receive |
|---|---|---|
| flucloxacillin + phenoxymethylpenicillin | Active comparator | Flucloxacillin 500 mg four times daily + Phenoxymethylpenicillin 500 mg four times daily for 7 days. Receives: Drug: Flucloxacillin; Drug: Phenoxymethylpenicillin |
| flucloxacillin + placebo | Placebo comparator | Flucloxacillin 500 mg four times daily + Placebo four times daily for 7 days. Receives: Drug: Flucloxacillin; Drug: Placebo (for phenoxymethylpenicillin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-determined clinical response
A trained member of the study team will determine clinical cure at the test of cure visit. This is a clinically-determined response to treatment based on the judgment of the trained member of the study team. Clinical cure will be defined as no treatment failure at any previous visit, and resolution or minimal presence of the erythema, swelling, tenderness, or induration from the baseline assessment, based on the study investigators clinical assessment
Measured: Test Of Cure visit (Day 14-21 post randomization)
Secondary outcomes (8)
Early Clinical Response (ECR)
Early clinical response is defined as greater than or equal to a 20% reduction in the lesion surface area from that which was measured at enrolment.
Measured: Day 2-3 post randomization
Clinical Treatment Failure
Any patient outcome designated as a clinical treatment failure at any time before and including the test of cure visit, will be categorized as a treatment failure. This commences with the early clinical response visit and includes serial changes in the surface area of the cellulitis lesion (erythema, oedema, tenderness and induration), clinical assessment of progress and health related quality of life measurements.
Measured: Up to 21 days post randomization
Adherence to Medication
Medication adherence will be measured by counting the number of unused study medication at the end of treatment visit
Measured: End of Treatment (EOT) visit Day 8-10 post randomization
Adherence to medication using an electronic medication event monitoring system (MEMS®)
A specific sub-study will be performed measuring adherence and persistence to antibiotic treatment using a MEMS® cap. The cap will be fitted to the dispensed medication bottle. MEMS® caps will be returned with the clinical trials supplies on the follow up visits.medication at the end of treatment visit
Measured: Day 2-3 and day 8-10 post randomization and initiation of therapy
Measurement of Health Related Quality of Life
The EuroQol (EQ-5D-5L) will be used to obtain patient reports of health related quality of life and used in the estimation of quality adjusted life years.
Measured: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization
Validation of the Extremity Soft Tissue Infections (ESTI)- score
The ESTI will be used to obtain patient reports of health related quality of life and will be mapped on to EQ-5D-5L levels, to assess the accuracy of ESTI for use in cost-effectiveness studies
Measured: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization
Cost-effectiveness analysis
Analysis will consist of a within-trial evaluation of the cost QALY for oral flucloxacillin compared with oral flucloxacillin and phenoxymethylpenicillin over a one month time horizon from the perspective of the healthcare payer, the patient and the government. The CE analysis will use resource use data, where costs will be assigned to derive cost and will also use the QALY derived from the EQ5D-5L, to give overall cost per QALY.
Measured: Day 14 - 21 post randomization
Measurement of Health Resource Use
A health economics resource utilization tool is being constructed to collect data on resource use, e.g. direct costs- hospital visits, primary care visits, and indirect costs such as transport and lost work productivity.
Measured: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CellulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Sponsor
- Investigators
- Adrian Moughty, Principal investigator, Mater Misericordiae University HospitalJoseph McKeever, Principal investigator, Connolly Hospital BlanchardstownConor Deasy, Principal investigator, Department of Emergency Medicine, Cork University Hopsital, CorkChris Luke, Principal investigator, Department of Emergency Medicine, Mercy University, CorkAbel Wakai, MD FRCEM, Principal investigator, Department of Emergency Medicine, Beaumont Hospital, Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922686
- Sponsor's protocol ID
- EudraCT Number: 2016-001528-69
- Other IDs
- HRB HRA Project ID
- Acronym
- PEDOCELL
- Status last verified
- Jul 2016
- First submitted
- 9 Aug 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Quirke M, Saunders J, O'Sullivan R, Milenkovski H, Wakai A. A pilot cross-sectional study of patients presenting with cellulitis to emergency departments. Ir Med J. 2014 Nov-Dec;107(10):316-8.
PubMed 25556256Dong SL, Kelly KD, Oland RC, Holroyd BR, Rowe BH. ED management of cellulitis: a review of five urban centers. Am J Emerg Med. 2001 Nov;19(7):535-40. doi: 10.1053/ajem.2001.28330.
PubMed 11698996Kilburn SA, Featherstone P, Higgins B, Brindle R. Interventions for cellulitis and erysipelas. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD004299. doi: 10.1002/14651858.CD004299.pub2.
PubMed 20556757Storck AJ, Laupland KB, Read RR, Mah MW, Gill JM, Nevett D, Louie TJ. Development of a Health-Related Quality of Life Questionnaire (HRQL) for patients with Extremity Soft Tissue Infections (ESTI). BMC Infect Dis. 2006 Oct 11;6:148. doi: 10.1186/1471-2334-6-148.
PubMed 17034641Quirke M, O'Sullivan R, McCabe A, Ahmed J, Wakai A. Are two penicillins better than one? A systematic review of oral flucloxacillin and penicillin V versus oral flucloxacillin alone for the emergency department treatment of cellulitis. Eur J Emerg Med. 2014 Jun;21(3):170-4. doi: 10.1097/MEJ.0b013e328360d980.
PubMed 23542420Boland F, Quirke M, Gannon B, Plunkett S, Hayden J, McCourt J, O'Sullivan R, Eustace J, Deasy C, Wakai A. The Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP). Trials. 2017 Aug 24;18(1):391. doi: 10.1186/s13063-017-2121-2.
PubMed 28836993
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Flucloxacillin Alone Versus Flucloxacillin and Phenoxymethylpenicillin for the Emergency Department Outpatient Treatment of Cellulitis: a Non-inferiority Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02922686
- Acronym / sponsor ID
- PEDOCELL / EudraCT Number: 2016-001528-69
- Conditions
- Cellulitis, Wound Infection, Abscess
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to investigate the non-inferiority of oral flucloxacillin alone compared with a combination of oral flucloxacillin and phenoxymethylpenicillin for the emergency department directed outpatient treatment of cellulitis, wound infections and abscesses, recently renamed by the Food and Drug Administration (FDA) as acute bacterial skin and skin structure infections (ABSSSIs). Half of the trial participants will receive flucloxacillin and placebo in combination, and the remaining half will be treated will flucloxacillin and phenoxymethylpenicillin.
In a secondary objective the trial aims to measure adherence and persistence of trial patients with outpatient antibiotic therapy. In addition a within-trial evaluation of the cost per quality adjusted life year (QALY) gained from the use of oral flucloxacillin compared with combination therapy from the perspective of the health-care payer (direct costs) the patient and government. Finally the study will externally validate the Extremity Soft Tissue Infection-score, a Health Related Quality of Life (HRQL) questionnaire designed to quantify the impact of cellulitis, wound infections and abscesses on patient HRQL in clinical trials.
Detailed description
There is obvious clinical equipoise between the use of oral flucloxacillin alone or combined with phenoxymethylpenicillin for the emergency department treatment of cellulitis, wound infections and abscesses as evidenced by current disparate prescribing practice and hospital guidelines. Feasibility studies for the planned trial have shown that 45-50% of emergency department patients with these infections in Ireland are discharged on oral antibiotics which is consistent with findings in other jurisdictions. Despite the significant healthcare and economic costs associated with cellulitis, there is a paucity of scientific evidence concerning the appropriate antibiotic treatment for these conditions. Additionally, "less severe" infections tend to be over-treated and severe infections under-treated, indicating unjustifiable levels of antibiotic misuse, insufficient knowledge of therapeutics and a lack of evidence to risk-stratify patients with cellulitis to different treatments.The planned trial is therefore likely to be definitive due to the current clinical equipoise between the use of both penicillins for the emergency department outpatient treatment of this group of infections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flucloxacillin + phenoxymethylpenicillin | Active comparator | Drug: Flucloxacillin, Drug: PhenoxymethylpenicillinFlucloxacillin 500 mg four times daily + Phenoxymethylpenicillin 500 mg four times daily for 7 days. |
| flucloxacillin + placebo | Placebo comparator | Drug: Flucloxacillin, Drug: Placebo (for phenoxymethylpenicillin)Flucloxacillin 500 mg four times daily + Placebo four times daily for 7 days. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Clinically diagnosed cellulitis, wound infections or abscess (ABSSSI) affecting any body part, excluding the perineum, and having any two of the following signs:
- Cellulitis, wound infection and abscess deemed treatable with oral outpatient antibiotics in which either combination of antibiotic is likely to produce a clinical response (Eron Class 1-2)
- Written informed consent obtained.
- 16 years of age or older.
- Fluency in written and spoken English.
Key exclusion criteria (15 listed)
- Penicillin allergy (self-reported or confirmed).
- Any cellulitis, wound infection and abscess that treating clinicians deem treatable with intravenous (IV) antibiotics.
- Any cellulitis, wound infection and abscess that is more severe than Eron Class 2 (Appendix 2)
- Any cellulitis, wound infection and abscess of the perineal region.
- Patients who have received more than 24 hours of effective antibiotics for the current episode of acute cellulitis, wound infection or abscess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlucloxacillinAlso: Floxapen, 500 mg Capsules,, Marketing Authorisation Number PA1380/011/002One flucloxacillin capsule of 500mg strength taken four times daily for 7 days | Drug | flucloxacillin + phenoxymethylpenicillin, flucloxacillin + placebo |
| PhenoxymethylpenicillinAlso: Marketing Authorisation Number PL; 04520/0005One capsule of phenoxymethylpenicillin of 500 mg strength taken four times daily for 7 days | Drug | flucloxacillin + phenoxymethylpenicillin |
| Placebo (for phenoxymethylpenicillin)Also: Over-encapsulated investigative medicinal product.Over-encapsulation of phenoxymethylpenicillin will be performed by the manufacturer of the investigational medicinal products such that placebo and active phenoxymethylpenicillin are identical in size, shape, colour and smell, and are packaged in identical bottles | Drug | flucloxacillin + placebo |
Primary outcome
Investigator-determined clinical response
Time frame: Test Of Cure visit (Day 14-21 post randomization)
A trained member of the study team will determine clinical cure at the test of cure visit. This is a clinically-determined response to treatment based on the judgment of the trained member of the study team. Clinical cure will be defined as no treatment failure at any previous visit, and resolution or minimal presence of the erythema, swelling, tenderness, or induration from the baseline assessment, based on the study investigators clinical assessment
8 secondary outcomes
Early Clinical Response (ECR)
Time frame: Day 2-3 post randomization
Clinical Treatment Failure
Time frame: Up to 21 days post randomization
Adherence to Medication
Time frame: End of Treatment (EOT) visit Day 8-10 post randomization
Adherence to medication using an electronic medication event monitoring system (MEMS®)
Time frame: Day 2-3 and day 8-10 post randomization and initiation of therapy
Measurement of Health Related Quality of Life
Time frame: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization
Validation of the Extremity Soft Tissue Infections (ESTI)- score
Time frame: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization
Cost-effectiveness analysis
Time frame: Day 14 - 21 post randomization
Measurement of Health Resource Use
Time frame: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Background: PubMed 25556256Quirke M, Saunders J, O'Sullivan R, Milenkovski H, Wakai A. A pilot cross-sectional study of patients presenting with cellulitis to emergency departments. Ir Med J. 2014 Nov-Dec;107(10):316-8.
- Background: PubMed 11698996Dong SL, Kelly KD, Oland RC, Holroyd BR, Rowe BH. ED management of cellulitis: a review of five urban centers. Am J Emerg Med. 2001 Nov;19(7):535-40. doi: 10.1053/ajem.2001.28330.
- Background: PubMed 20556757Kilburn SA, Featherstone P, Higgins B, Brindle R. Interventions for cellulitis and erysipelas. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD004299. doi: 10.1002/14651858.CD004299.pub2.
- Background: PubMed 17034641Storck AJ, Laupland KB, Read RR, Mah MW, Gill JM, Nevett D, Louie TJ. Development of a Health-Related Quality of Life Questionnaire (HRQL) for patients with Extremity Soft Tissue Infections (ESTI). BMC Infect Dis. 2006 Oct 11;6:148. doi: 10.1186/1471-2334-6-148.
- Background: PubMed 23542420Quirke M, O'Sullivan R, McCabe A, Ahmed J, Wakai A. Are two penicillins better than one? A systematic review of oral flucloxacillin and penicillin V versus oral flucloxacillin alone for the emergency department treatment of cellulitis. Eur J Emerg Med. 2014 Jun;21(3):170-4. doi: 10.1097/MEJ.0b013e328360d980.
- Derived from this study: PubMed 28836993Boland F, Quirke M, Gannon B, Plunkett S, Hayden J, McCourt J, O'Sullivan R, Eustace J, Deasy C, Wakai A. The Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP). Trials. 2017 Aug 24;18(1):391. doi: 10.1186/s13063-017-2121-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Moughty principal investigator
Mater Misericordiae University Hospital
Joseph McKeever principal investigator
Connolly Hospital Blanchardstown
Conor Deasy principal investigator
Department of Emergency Medicine, Cork University Hopsital, Cork
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flucloxacillin and Phenoxymethylpenicillin in people with Cellulitis and Wound Infection, run by Royal College of Surgeons, Ireland at 5 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abel Wakai, MD FRCEM (003531 8093000, awakai@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-determined clinical response (time frame: Test Of Cure visit (Day 14-21 post randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02922686, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.