RhinoscleromaPhase 1NCT05431673
Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma
A Phase 1 study testing Doxycycline, Ciprofloxacin and Rifampin in people with Rhinoscleroma, run by Assiut University.
Trial summary
The study is conducted To evaluate the Efficacy of Doxycycline (alone and in combination with Ciprofloxacin) as an alternative to the regular regimen in treating rhinoscleroma, especially for cases with contraindication to the use of one or more of the regularly used drugs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rhinoscleroma
- What is being tested?
- Doxycycline, Ciprofloxacin and Rifampin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 21 Aug 2022to 31 Jul 2023
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be included after confirmation by histopathological examination.
- Patients presented in active stages of the disease.
- Patients between 18-70 years.
Who cannot join
- Any granulomatous lesion or features suggestive of rhinoscleroma associated with any other nasal lesions like syphilis, leprosy and tuberculosis were excluded.
- Patients below 18 years and above 70 years.
- Biopsy-negative cases.
- Patients in Atrophic or Sclerotic Stages of the disease.
Trial locations and contacts
No sites are listed yet.
About this study
The study is conducted To evaluate the Efficacy of Doxycycline (alone and in combination with Ciprofloxacin) as an alternative to the regular regimen in treating rhinoscleroma, especially for cases with contraindication to the use of one or more of the regularly used drugs.
Read the detailed description
Rhinoscleroma is a chronic granulomatous disease endemic in many eastern countries including Egypt, Its causative agent is a gram-negative bacillus, Klebsiella rhinoscleromatis. Low socioeconomic populations are the most affected.. There are four known stages of the lesion. The first of which the 'Catarrhal stage' with purulent rhinorrhea, then there is the 'Atrophic stage' with a picture similar to that of atrophic rhinitis. The next is the 'Hypertrophic' or 'Granulomatous' stage where there are bluish red rubbery nodules in any part along the distribution of the disease, and eventually the 'Fibrotic' or 'Sclerotic' stage with stenosis deformity and loss of functions of the parts affected. Examples of commonly used drugs are 'Rifampicin' which is the most commonly used drug exhibits good results but the need for close monitoring for fear of toxicity is the only limitation to its use, Ciprofloxacin' is another Antibiotic with special efficacy as it has good tissue penetration \& produces high concentrations in respiratory tract secretions. Recently 'Doxycycline' has been approved to be used in rhinoscleroma which has the advantage of not only easier dosing but also better patient compliance as it's used for a shorter course (6 weeks) compared to most other drugs.
- Conditions
- Rhinoscleroma
- Being tested
- Doxycycline, Ciprofloxacin, Rifampin
- Keywords
- doxycycline
- Medical subject headings
- Rhinoscleroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline 100mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma
CiprofloxacinDrug
Ciprofloxacin 500mg/day for 4 weeks used as single or combination treatment for Rhinoscleroma
RifampinDrug
Rifampin 600mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Active comparator | • Subjects in this group will be treated with Doxycycline (100mg/day for 8 weeks).[1] Receives: Drug: Doxycycline |
| Doxycycline & Ciprofloxacin | Active comparator | • Subjects in this group will be treated with combination of Doxycycline (100mg/day for 8 weeks) \& Ciprofloxacin (250mg twice daily for 4 weeks).[1] Receives: Drug: Doxycycline; Drug: Ciprofloxacin |
| Rifampicin | Active comparator | • Subjects in this group will be treated with Rifampicin (600mg/day for 6 weeks) Receives: Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients showing post treatment histopathologic resolution
Comparing Histopathologic changes pre and post intervention for the 3 groups and the number of participants whose post treatment biopsy show histopathologic resolution will be measued as percentage to the total number of participants in each group
Measured: 8 months from the start of treatment
Secondary outcomes (1)
Nasal Symptoms
All participants will be asked to score 5 nasal symptoms (nasal congestion/obstruction, anterior rhinorrhea, posterior rhinorrhea, loss of smell and facial pain.) from 0 to 4.
0= no symptoms
- mild symptoms
- moderate symptoms
- sever symptoms
- very sever symptoms this score will be assessed at the screening visit \& follow up visits at 8 weeks , 6 months. the total five-symptom score obtained will be the sum of the individual symptoms(0-20)
Measured: 8 months from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start21 Aug 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (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 RhinoscleromaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 Groups A will receive Doxycycline B will receive Ciprofloxacin and Doxycycline C will receive Rifampin
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Mohamad Omar, Assiut University
- Investigators
- Ahmed AbdelAleem, PhD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431673
- Sponsor's protocol ID
- Doxycycline in Rhinoscleroma
- Status last verified
- Jul 2022
- First submitted
- 14 Dec 2021
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kallapa S, Sarkar SR, Shankar MG. Effectiveness of ciprofloxacin vs. doxycycline in treatment of rhinoscleroma- A case-control study. J. Evid. Based Med. Healthc. 2017; 4(20), 1165-1168
Abou-Seif SG, Baky FA, el-Ebrashy F, Gaafar HA. Scleroma of the upper respiratory passages: a CT study. J Laryngol Otol. 1991 Mar;105(3):198-202. doi: 10.1017/s0022215100115348.
PubMed 2019806Badia L, Lund VJ. A case of rhinoscleroma treated with ciprofloxacin. J Laryngol Otol. 2001 Mar;115(3):220-2. doi: 10.1258/0022215011907028.
PubMed 11244532Cone LA, Barton SM, Woodard DR. Treatment of scleroma with ceforanide. Arch Otolaryngol Head Neck Surg. 1987 Apr;113(4):374-6. doi: 10.1001/archotol.1987.01860040036012.
PubMed 3814386Jage M, Rambhia KD, Khopkar US. Efficacy of doxycyclin monotherapy in treating rhinoscleroma. Indian J Drugs Dermatol 2018;4:23-5
Menzies D, Benedetti A, Paydar A, Martin I, Royce S, Pai M, Vernon A, Lienhardt C, Burman W. Effect of duration and intermittency of rifampin on tuberculosis treatment outcomes: a systematic review and meta-analysis. PLoS Med. 2009 Sep;6(9):e1000146. doi: 10.1371/journal.pmed.1000146. Epub 2009 Sep 15.
PubMed 19753109
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma
- ClinicalTrials.gov ID
- NCT05431673
- Acronym / sponsor ID
- Doxycycline in Rhinoscleroma
- Conditions
- Rhinoscleroma
- Keywords
- doxycycline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 21 Aug 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 24 Jun 2022 (actual)
- 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 study is conducted To evaluate the Efficacy of Doxycycline (alone and in combination with Ciprofloxacin) as an alternative to the regular regimen in treating rhinoscleroma, especially for cases with contraindication to the use of one or more of the regularly used drugs.
Detailed description
Rhinoscleroma is a chronic granulomatous disease endemic in many eastern countries including Egypt, Its causative agent is a gram-negative bacillus, Klebsiella rhinoscleromatis. Low socioeconomic populations are the most affected.. There are four known stages of the lesion. The first of which the 'Catarrhal stage' with purulent rhinorrhea, then there is the 'Atrophic stage' with a picture similar to that of atrophic rhinitis. The next is the 'Hypertrophic' or 'Granulomatous' stage where there are bluish red rubbery nodules in any part along the distribution of the disease, and eventually the 'Fibrotic' or 'Sclerotic' stage with stenosis deformity and loss of functions of the parts affected. Examples of commonly used drugs are 'Rifampicin' which is the most commonly used drug exhibits good results but the need for close monitoring for fear of toxicity is the only limitation to its use, Ciprofloxacin' is another Antibiotic with special efficacy as it has good tissue penetration \& produces high concentrations in respiratory tract secretions. Recently 'Doxycycline' has been approved to be used in rhinoscleroma which has the advantage of not only easier dosing but also better patient compliance as it's used for a shorter course (6 weeks) compared to most other drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 3 Groups A will receive Doxycycline B will receive Ciprofloxacin and Doxycycline C will receive Rifampin
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Active comparator | Drug: Doxycycline• Subjects in this group will be treated with Doxycycline (100mg/day for 8 weeks).[1] |
| Doxycycline & Ciprofloxacin | Active comparator | Drug: Doxycycline, Drug: Ciprofloxacin• Subjects in this group will be treated with combination of Doxycycline (100mg/day for 8 weeks) \& Ciprofloxacin (250mg twice daily for 4 weeks).[1] |
| Rifampicin | Active comparator | Drug: Rifampin• Subjects in this group will be treated with Rifampicin (600mg/day for 6 weeks) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients will be included after confirmation by histopathological examination.
- Patients presented in active stages of the disease.
- Patients between 18-70 years.
Key exclusion criteria (4 listed)
- Any granulomatous lesion or features suggestive of rhinoscleroma associated with any other nasal lesions like syphilis, leprosy and tuberculosis were excluded.
- Patients below 18 years and above 70 years.
- Biopsy-negative cases.
- Patients in Atrophic or Sclerotic Stages of the disease.
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 |
|---|---|---|
| DoxycyclineDoxycycline 100mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma | Drug | Doxycycline, Doxycycline & Ciprofloxacin |
| CiprofloxacinCiprofloxacin 500mg/day for 4 weeks used as single or combination treatment for Rhinoscleroma | Drug | Doxycycline & Ciprofloxacin |
| RifampinRifampin 600mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma | Drug | Rifampicin |
Primary outcome
Percentage of patients showing post treatment histopathologic resolution
Time frame: 8 months from the start of treatment
Comparing Histopathologic changes pre and post intervention for the 3 groups and the number of participants whose post treatment biopsy show histopathologic resolution will be measued as percentage to the total number of participants in each group
1 secondary outcome
Nasal Symptoms
Time frame: 8 months from the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- BackgroundKallapa S, Sarkar SR, Shankar MG. Effectiveness of ciprofloxacin vs. doxycycline in treatment of rhinoscleroma- A case-control study. J. Evid. Based Med. Healthc. 2017; 4(20), 1165-1168
- Background: PubMed 2019806Abou-Seif SG, Baky FA, el-Ebrashy F, Gaafar HA. Scleroma of the upper respiratory passages: a CT study. J Laryngol Otol. 1991 Mar;105(3):198-202. doi: 10.1017/s0022215100115348.
- Background: PubMed 11244532Badia L, Lund VJ. A case of rhinoscleroma treated with ciprofloxacin. J Laryngol Otol. 2001 Mar;115(3):220-2. doi: 10.1258/0022215011907028.
- Background: PubMed 3814386Cone LA, Barton SM, Woodard DR. Treatment of scleroma with ceforanide. Arch Otolaryngol Head Neck Surg. 1987 Apr;113(4):374-6. doi: 10.1001/archotol.1987.01860040036012.
- BackgroundJage M, Rambhia KD, Khopkar US. Efficacy of doxycyclin monotherapy in treating rhinoscleroma. Indian J Drugs Dermatol 2018;4:23-5
- Background: PubMed 19753109Menzies D, Benedetti A, Paydar A, Martin I, Royce S, Pai M, Vernon A, Lienhardt C, Burman W. Effect of duration and intermittency of rifampin on tuberculosis treatment outcomes: a systematic review and meta-analysis. PLoS Med. 2009 Sep;6(9):e1000146. doi: 10.1371/journal.pmed.1000146. Epub 2009 Sep 15.
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.
Ahmed AbdelAleem, PhD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxycycline, Ciprofloxacin and Rifampin in people with Rhinoscleroma, run by Assiut University.
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 3 inclusion and 4 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 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Abdullah Omar, Bachelor (00201125073607, Dramomo95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients showing post treatment histopathologic resolution (time frame: 8 months from the start of treatment). 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 NCT05431673, 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 7 Jul 2022.