Crohn's Disease Clinical Trial
— APRiCCOTOfficial title:
A Pilot Randomised Study to Compare Combination Antibiotic Therapy (Ciprofloxacin, Doxycycline and Hydroxychloroquine) With Standard Therapy (Budesonide) in the Treatment of Active Crohn's Disease
Verified date | October 2019 |
Source | Royal Liverpool University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There is growing evidence that Crohn's disease may be caused by replication of bacteria, perhaps particularly E. coli, within macrophages (a specialized sort of white blood cell). Laboratory studies show that a combination of antibiotics that can penetrate macrophages (such as ciprofloxacin and doxycycline) together with the anti-malarial drug hydroxychloroquine (which makes the contents of macrophage vesicles more alkaline and helps them to kill intracellular bacteria) is particularly effective at killing the E. coli within macrophages.
Status | Completed |
Enrollment | 59 |
Est. completion date | September 30, 2019 |
Est. primary completion date | April 18, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient is willing to participate in the study and has signed the informed consent - Patients aged 18 or over with Crohn's disease diagnosed by conventional clinical, radiological and histological criteria. - Crohn's disease involving small bowel, colon or both. - Active Crohn's disease: Crohn's Disease Activity Index (CDAI)> 220 and CRP>10mg/l. - Patients receiving mesalazine (5ASA) must have had a stable dose for at least one month. - Patients receiving Azathioprine, or Mercaptopurine (who will be separately stratified) must have had a stable dose for at least 3 months - Women of child bearing potential must have a negative urine pregnancy test prior to the start of study medication Exclusion Criteria: - Patients under 18 or unable to give informed consent. - Any antibiotic use within the previous 4 weeks - Known sensitivity to Ciprofloxacin, Doxycycline, Hydroxychloroquine, or Budesonide - Patients with a history of tendon disorders related to Fluoroquinoline administration - Any change to immunosuppressive therapy (Azathioprine, or Mercaptopurine) within the previous 3 months. - Use of Infliximab or Adalimumab (anti-TNF antibody) or methotrexate within the previous 3 months - Concurrent use of systemic corticosteroids in excess of oral prednisolone 5 mgs/day or budesonide 3mg/day) - Any change to medication for Crohn's disease in previous 4 weeks. - Patients with complications requiring surgery (significant intestinal obstruction, perforation or abscess) - CDAI >450 - Participation in other trials in the last 3 months. - Serious intercurrent infection or other clinically important active disease (including renal and hepatic disease) - Pregnant, post-partum (<3months) or breast feeding females - Patients with abnormal visual acuity (that does not correct with glasses) or unexplained visual symptoms - Women of Child Bearing Potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period (double barrier methods such as condoms or diaphragms with spermicidal gel or foam), and for up to 4 weeks after the study. - Patients who need to continue to receive oral contraceptives (if unwilling to use double barrier methods), oral anticoagulants tricyclic antidepressants, non-steroidal anti-inflammatory drugs (NSAIDs), anticonvulsants, Sucralfate, or Cyclosporine |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Liverpool and Broadgreen Unversity Hospitals Trust | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Royal Liverpool University Hospital | National Association for Colitis and Crohn's Disease, National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | • Remission, defined as Crohn's Disease activity index (CDAI) <150 at 10 weeks without addition of any other medication or treatment for the Crohn's Disease. | Remission | 10 weeks | |
Primary | • Remission, defined as CDAI =150 maintained through to 24 weeks | prolonged remission | 24 weeks | |
Primary | • Remission, defined as CDAI =150 maintained through to 52 weeks | prolonged remission | 52 weeks | |
Secondary | • Remission defined as CDAI <150 at 4 weeks | remission | 4 weeks | |
Secondary | • Response defined as a fall in CDAI by >70 points at 4 weeks and 10 weeks | response | 4 weeks and 10 weeks | |
Secondary | • Markers of cost (days admitted to hospital, days unable to carry out normal daily activities, need for surgery) | cost effectiveness | 52 weeks | |
Secondary | • Quality of life at 4 weeks, at 10 weeks, or Early Withdrawal | Quality of life | 4 weeks and 10 weeks | |
Secondary | • Patient global assessment of symptom severity by 10 cm visual analogue score at 4 weeks, at 10 weeks, or Early Withdrawal | efficacy | 4 weeks and 10 weeks | |
Secondary | • Adverse Events and possible drug-related side effects: nausea, diarrhoea, mood disturbance, sleep disturbance - will all be assessed at each visit | adverse event monitoring | throughout 12 month follow-up | |
Secondary | • Fall in Faecal Calprotectin | efficacy | 4 weeks, 10 weeks, 24 weeks, 52 weeks |
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