Rocky Mountain Spotted FeverPhase 3Rocky-ZNCT05398055
Efficacy of Azithromycin Plus Doxycycline Versus Doxycycline Plus Placebo in Patients With Rocky Mountain Spotted Fever
A Phase 3 study testing Azithromycin + Doxycycline in people with Rocky Mountain Spotted Fever, run by Hospital General de Mexicali at 1 site in Mexico.
Trial summary
The aim of this study is to impove the pharmacological treatment of Rocky mountain spotted fever, since is a very ancient disease with an antibiotic therapy that have not changed much the mortality rates, being compared with the natural curse of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rocky Mountain Spotted Fever
- What is being tested?
- Azithromycin + Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteMexico
- Study dates
- 12 May 2022to 31 Dec 2025
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any gender
- Over 18 years old
- hospitalized in the internal medicine service, emergency department or intensive care unit of Hospital General de Mexicali (ISESALUD) or Hospital General Zona No. 30 (IMSS) with suspicion of RMSF that present fever and 2 or more of the next symptoms: headache, myalgia, rash, nausea, pharyngeal hyperemia, vomiting, abdominal pain, neurological disorders.
- In addition to at least one of the next epidemiologycal fators: presence of vectors in areas of residence or endemic areas visited two weeks prior to the onset of symptoms, history of visiting or residing in areas with RMSF transmission in the last two weeks, existence of confirmed cases in the locality of origin, history of vector bite or contact with dogs in the two weeks.
Who cannot join
- Other clinical suspicion rather than RMSF
- History of allergy to doxycycline, azithromycin, bean starch or bovine gelatin.
- Not signing the informed consent
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de Mexicali
Mexicali, Estado de Baja California, 21000
Hiram J. Jaramillo-Ramirez, MD, 686 135 8412, grupoinvestigacionmedica@gmail.com
About this study
Official title: Efficacy of Azithromycin Plus Doxycycline Compared to Doxycycline Plus Placebo in Patients With Rocky Mountain Spotted Fever in Hospital General de Mexicali of ISESALUD and Hospital General No. 30 Instituto Mexicano Del Seguro Social
The aim of this study is to impove the pharmacological treatment of Rocky mountain spotted fever, since is a very ancient disease with an antibiotic therapy that have not changed much the mortality rates, being compared with the natural curse of the disease.
Read the detailed description
Rocky mountain spotted fever is a potentially fatal infectious disease wich is transmitted trough vectors. This particular infection is caused by Rickettsia rickettsii wich is a gramnegative intracellular bacilli. The pathophysiological mechanism and clinical manifestation is mainly due to the vascular affectation, since this pathogen has a tropism for endothelial cells. As it has been mentioned, this is an obligate intracellular pathogen, so the main choice with the antibiotic therapy is tetracyclines because of its action mechanism in the inhibition of the subunit 30S. The objective of the study is to prove new strategies of treatment to improve the pharmacological aproach by implementing Azithromycin, wich is a macrolide that inhibits de 50S subunit of the bacteria. Azithromycin has shown effectivity against other rickettsial diseases.
- Conditions
- Rocky Mountain Spotted Fever
- Being tested
- Azithromycin + Doxycycline, Placebo + Doxycycline
- Keywords
- Rocky Mountain Spotted Fever, Azithromycin, Doxycycline
- Medical subject headings
- Rocky Mountain Spotted Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin + DoxycyclineDrug
Also called A
azithromycin 500 mg orally every 24 hours for three dose plus doxycycline 100 mg orally every 12 hours for 7 days
Placebo + DoxycyclineDrug
Also called B
doxycycline 100 mg orally every 12 hours for 7 days plus placebo 1 capsule every 24 hours, 3 doses
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Azithromycine group Receives: Drug: Azithromycin + Doxycycline |
| B | Placebo comparator | Placebo group Receives: Drug: Placebo + Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality of azithromycin plus doxycycline vs doxycycline plus placebo
Measured: 3 years
Secondary outcomes (4)
Number of hospitalization days in each arm
Measured: 3 years
Number of participants with renal replacement therapy.
Measured: 3 years
Number of participants that required amines in both groups.
Measured: 3 years
Number of fever days in both arms.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start12 May 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rocky Mountain Spotted FeverStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled randomized trial with placebo, triple blinded, multicenter study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexicali
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiram Jaramillo Ramirez, Hospital General de Mexicali
- Investigators
- Hiram J Jaramillo-Ramirez, MD, Principal investigator, Hospital General de Mexicali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398055
- Sponsor's protocol ID
- 02-01//2022-05-09-066-20
- Acronym
- Rocky-Z
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Azithromycin Plus Doxycycline Compared to Doxycycline Plus Placebo in Patients With Rocky Mountain Spotted Fever in Hospital General de Mexicali of ISESALUD and Hospital General No. 30 Instituto Mexicano Del Seguro Social
- ClinicalTrials.gov ID
- NCT05398055
- Acronym / sponsor ID
- Rocky-Z / 02-01//2022-05-09-066-20
- Conditions
- Rocky Mountain Spotted Fever
- Keywords
- Rocky Mountain Spotted Fever, Azithromycin, Doxycycline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Hospital General de MexicaliUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 May 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 aim of this study is to impove the pharmacological treatment of Rocky mountain spotted fever, since is a very ancient disease with an antibiotic therapy that have not changed much the mortality rates, being compared with the natural curse of the disease.
Detailed description
Rocky mountain spotted fever is a potentially fatal infectious disease wich is transmitted trough vectors. This particular infection is caused by Rickettsia rickettsii wich is a gramnegative intracellular bacilli. The pathophysiological mechanism and clinical manifestation is mainly due to the vascular affectation, since this pathogen has a tropism for endothelial cells. As it has been mentioned, this is an obligate intracellular pathogen, so the main choice with the antibiotic therapy is tetracyclines because of its action mechanism in the inhibition of the subunit 30S. The objective of the study is to prove new strategies of treatment to improve the pharmacological aproach by implementing Azithromycin, wich is a macrolide that inhibits de 50S subunit of the bacteria. Azithromycin has shown effectivity against other rickettsial diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Controlled randomized trial with placebo, triple blinded, multicenter study
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Azithromycin + DoxycyclineAzithromycine group |
| B | Placebo comparator | Drug: Placebo + DoxycyclinePlacebo group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any gender
- Over 18 years old
- hospitalized in the internal medicine service, emergency department or intensive care unit of Hospital General de Mexicali (ISESALUD) or Hospital General Zona No. 30 (IMSS) with suspicion of RMSF that present fever and 2 or more of the next symptoms: headache, myalgia, rash, nausea, pharyngeal hyperemia, vomiting, abdominal pain, neurological disorders.
- In addition to at least one of the next epidemiologycal fators: presence of vectors in areas of residence or endemic areas visited two weeks prior to the onset of symptoms, history of visiting or residing in areas with RMSF transmission in the last two weeks, existence of confirmed cases in the locality of origin, history of vector bite or contact with dogs in the two weeks.
Key exclusion criteria (4 listed)
- Other clinical suspicion rather than RMSF
- History of allergy to doxycycline, azithromycin, bean starch or bovine gelatin.
- Not signing the informed consent
- Pregnancy.
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 |
|---|---|---|
| Azithromycin + DoxycyclineAlso: Aazithromycin 500 mg orally every 24 hours for three dose plus doxycycline 100 mg orally every 12 hours for 7 days | Drug | A |
| Placebo + DoxycyclineAlso: Bdoxycycline 100 mg orally every 12 hours for 7 days plus placebo 1 capsule every 24 hours, 3 doses | Drug | B |
Primary outcome
Mortality of azithromycin plus doxycycline vs doxycycline plus placebo
Time frame: 3 years
4 secondary outcomes
Number of hospitalization days in each arm
Time frame: 3 years
Number of participants with renal replacement therapy.
Time frame: 3 years
Number of participants that required amines in both groups.
Time frame: 3 years
Number of fever days in both arms.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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.
Hiram J Jaramillo-Ramirez, MD principal investigator
Hospital General de Mexicali
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin + Doxycycline in people with Rocky Mountain Spotted Fever, run by Hospital General de Mexicali at 1 site in Mexico.
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 4 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 31 May 2022. 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 Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Hiram J. Jaramillo-Ramirez, MD (686 135 8412, grupoinvestigacionmedica@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality of azithromycin plus doxycycline vs doxycycline plus placebo (time frame: 3 years). 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 31 May 2022.