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

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.

Study Overview

• Status: Recruiting
• Conditions: Rocky Mountain Spotted Fever
• Intervention / Treatment: Drug: Azithromycin + Doxycycline; Drug: Placebo + Doxycycline

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 Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hiram J. Jaramillo-Ramirez, MD; Phone Number: 686 135 8412; Email: grupoinvestigacionmedica@gmail.com
• Study Contact Backup: Name: Gisel V. Licon-Martinez, MD; Phone Number: 686 194 5903; Email: viviana.licon@uabc.edu.mx

Study Locations

• Mexico
  • Baja California
    • Mexicali, Baja California, Mexico, 21000
      • Recruiting
      • Hospital General de Mexicali
      • Contact: Hiram J. Jaramillo-Ramirez, MD; Phone Number: 686 135 8412; Email: grupoinvestigacionmedica@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Azithromycine group	Drug: Azithromycin + Doxycycline; azithromycin 500 mg orally every 24 hours for three dose plus doxycycline 100 mg orally every 12 hours for 7 days; Other Names: A
PLACEBO_COMPARATOR: B; Placebo group	Drug: Placebo + Doxycycline; doxycycline 100 mg orally every 12 hours for 7 days plus placebo 1 capsule every 24 hours, 3 doses; Other Names: B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality of azithromycin plus doxycycline vs doxycycline plus placebo	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of hospitalization days in each arm	3 years
Number of participants with renal replacement therapy.	3 years
Number of participants that required amines in both groups.	3 years
Number of fever days in both arms.	3 years

Collaborators and Investigators

• Sponsor: Hospital General de Mexicali
• Investigators: Principal Investigator: Hiram J Jaramillo-Ramirez, MD, Hospital General de Mexicali

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 12, 2022
• Primary Completion (ANTICIPATED): December 31, 2025
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (ACTUAL): May 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Azithromycin; Doxycycline; Rocky Mountain Spotted Fever
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Body Temperature Changes; Tick-Borne Diseases; Rickettsia Infections; Rickettsiaceae Infections; Fever; Spotted Fever Group Rickettsiosis; Rocky Mountain Spotted Fever; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline; Azithromycin
• Other Study ID Numbers: 02-01//2022-05-09-066-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No