OnchocerciasisPhase 2NCT00127504
Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness
A Phase 2 study testing Rifampin and Azithromycin in people with Onchocerciasis, run by Centers for Disease Control and Prevention at 1 site in Guatemala.
Trial summary
The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis). Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Onchocerciasis
- What is being tested?
- Rifampin and Azithromycin
- How many people
- 80 participants
- Where
- 1 siteGuatemala
- Study dates
- Jul 2003to May 2004
- Phase
- Phase 2
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and non-pregnant/non lactating females >5 years of age
- One onchocercal nodule in an anatomical position where it can be easily removed surgically
Who cannot join
- Pregnancy (based on urine pregnancy test)
- Breast-feeding
- Women taking oral contraceptives
- Allergy or other adverse reaction to either medication
- Use of other medications that might interact with rifampin
- Clinical evidence of liver disease (jaundice, swollen abdomen)
- Clinical evidence of chronic disease/alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala
The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).
Read the detailed description
Mass treatment with ivermectin (Mectizan, Merck \& Co) is the mainstay of the current efforts to control onchocerciasis, but the drug is not lethal to adult Onchocerca volvulus parasites. Wolbachia, an endosymbiotic bacterium necessary for the fecundity of O. volvulus, can be eradicated with four-six week courses of doxycycline, but this cannot be implemented in current mass drug administration programs. The purpose of this study is to evaluate if a shorter course (five days) with antibiotics that could be used in children and potentially pregnant women would likewise be effective.
Guatemalan patients with onchocercal nodules will be enrolled in an open label trial with four treatment groups: Group A (rifampin 20 mg/kg by mouth [po; maximum 600 mg/day]); B (azithromycin 12 mg/kg po [maximum 500 mg/day]); C (combination of rifampin 20 mg/kg po [maximum 600 mg/day] and azithromycin 12 mg/kg po [maximum 500 mg/day]); D (control group, multivitamin). At the end of the five day treatment course all participants will receive a single dose of ivermectin (150 mcg/kg).
Nodulectomies will be performed 9 months after treatment and the O. volvulus will be analyzed by immunohistochemical staining specific for Wolbachia.
- Conditions
- Onchocerciasis
- Being tested
- Rifampin, Azithromycin
- Keywords
- Onchocerciasis, Wolbachia, Therapy
- Medical subject headings
- Onchocerciasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampinDrug
AzithromycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months
Secondary outcomes (1)
Elimination of microfilaria in skin snips and histological examination of worms after 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startJul 2003
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnchocerciasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Universidad del Valle, Guatemala, University of Alabama at Birmingham
- Investigators
- Josef Amann, MD, MPH, Principal investigator, CDC/NCID/DPD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127504
- Sponsor's protocol ID
- CDC-NCID-3843
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala
- ClinicalTrials.gov ID
- NCT00127504
- Acronym / sponsor ID
- CDC-NCID-3843
- Conditions
- Onchocerciasis
- Keywords
- Onchocerciasis, Wolbachia, Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Universidad del Valle, Guatemala, University of Alabama at Birmingham
- Study start
- Jul 2003
- Study completion
- May 2004
- First posted
- 8 Aug 2005 (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 purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).
Detailed description
Mass treatment with ivermectin (Mectizan, Merck \& Co) is the mainstay of the current efforts to control onchocerciasis, but the drug is not lethal to adult Onchocerca volvulus parasites. Wolbachia, an endosymbiotic bacterium necessary for the fecundity of O. volvulus, can be eradicated with four-six week courses of doxycycline, but this cannot be implemented in current mass drug administration programs. The purpose of this study is to evaluate if a shorter course (five days) with antibiotics that could be used in children and potentially pregnant women would likewise be effective.
Guatemalan patients with onchocercal nodules will be enrolled in an open label trial with four treatment groups: Group A (rifampin 20 mg/kg by mouth [po; maximum 600 mg/day]); B (azithromycin 12 mg/kg po [maximum 500 mg/day]); C (combination of rifampin 20 mg/kg po [maximum 600 mg/day] and azithromycin 12 mg/kg po [maximum 500 mg/day]); D (control group, multivitamin). At the end of the five day treatment course all participants will receive a single dose of ivermectin (150 mcg/kg).
Nodulectomies will be performed 9 months after treatment and the O. volvulus will be analyzed by immunohistochemical staining specific for Wolbachia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Males and non-pregnant/non lactating females >5 years of age
- One onchocercal nodule in an anatomical position where it can be easily removed surgically
Key exclusion criteria (7 listed)
- Pregnancy (based on urine pregnancy test)
- Breast-feeding
- Women taking oral contraceptives
- Allergy or other adverse reaction to either medication
- Use of other medications that might interact with rifampin
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 |
|---|---|---|
| Rifampin | Drug | – |
| Azithromycin | Drug | – |
Primary outcome
Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months
1 secondary outcome
Elimination of microfilaria in skin snips and histological examination of worms after 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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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.
Josef Amann, MD, MPH principal investigator
CDC/NCID/DPD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifampin and Azithromycin in people with Onchocerciasis, run by Centers for Disease Control and Prevention at 1 site in Guatemala.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2024.