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Efficacy of Azithromycin Plus Doxycycline Versus Doxycycline Plus Placebo in Patients With Rocky Mountain Spotted Fever (Rocky-Z)

Primary Purpose

Rocky Mountain Spotted Fever

Status
Recruiting
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Azithromycin + Doxycycline
Placebo + Doxycycline
Sponsored by
Hospital General de Mexicali
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rocky Mountain Spotted Fever focused on measuring Rocky Mountain Spotted Fever, Azithromycin, Doxycycline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Other clinical suspicion rather than RMSF
  • History of allergy to doxycycline, azithromycin, bean starch or bovine gelatin.
  • Not signing the informed consent
  • Pregnancy.

Sites / Locations

  • Hospital General de MexicaliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Azithromycine group

Placebo group

Outcomes

Primary Outcome Measures

Mortality of azithromycin plus doxycycline vs doxycycline plus placebo

Secondary Outcome Measures

Number of hospitalization days in each arm
Number of participants with renal replacement therapy.
Number of participants that required amines in both groups.
Number of fever days in both arms.

Full Information

First Posted
May 23, 2022
Last Updated
May 25, 2022
Sponsor
Hospital General de Mexicali
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1. Study Identification

Unique Protocol Identification Number
NCT05398055
Brief Title
Efficacy of Azithromycin Plus Doxycycline Versus Doxycycline Plus Placebo in Patients With Rocky Mountain Spotted Fever
Acronym
Rocky-Z
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de Mexicali

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rocky Mountain Spotted Fever
Keywords
Rocky Mountain Spotted Fever, Azithromycin, Doxycycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Controlled randomized trial with placebo, triple blinded, multicenter study
Masking
ParticipantCare ProviderInvestigator
Masking Description
Patients will be randomized through the program ¨Randomizer for Clinical Trial¨ to be assigned in group of treatment A or B. One of the treatments will be azithromycin 500 mg orally every 24 hours for three dose plus doxycycline 100 mg orally every 12 hours for 7 days and the other schedule it will be doxycycline 100 mg orally every 12 hours for 7 days plus placebo 1 capsule every 24 hours, 3 doses.
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Azithromycine group
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Drug
Intervention Name(s)
Azithromycin + Doxycycline
Other Intervention Name(s)
A
Intervention Description
azithromycin 500 mg orally every 24 hours for three dose plus doxycycline 100 mg orally every 12 hours for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo + Doxycycline
Other Intervention Name(s)
B
Intervention Description
doxycycline 100 mg orally every 12 hours for 7 days plus placebo 1 capsule every 24 hours, 3 doses
Primary Outcome Measure Information:
Title
Mortality of azithromycin plus doxycycline vs doxycycline plus placebo
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of hospitalization days in each arm
Time Frame
3 years
Title
Number of participants with renal replacement therapy.
Time Frame
3 years
Title
Number of participants that required amines in both groups.
Time Frame
3 years
Title
Number of fever days in both arms.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Other clinical suspicion rather than RMSF History of allergy to doxycycline, azithromycin, bean starch or bovine gelatin. Not signing the informed consent Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hiram J. Jaramillo-Ramirez, MD
Phone
686 135 8412
Email
grupoinvestigacionmedica@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gisel V. Licon-Martinez, MD
Phone
686 194 5903
Email
viviana.licon@uabc.edu.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiram J Jaramillo-Ramirez, MD
Organizational Affiliation
Hospital General de Mexicali
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de Mexicali
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiram J. Jaramillo-Ramirez, MD
Phone
686 135 8412
Email
grupoinvestigacionmedica@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Azithromycin Plus Doxycycline Versus Doxycycline Plus Placebo in Patients With Rocky Mountain Spotted Fever

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