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

Phase 3

Recruiting

• Conditions: Rocky Mountain Spotted Fever
• Interventions: Drug: Azithromycin + Doxycycline; Drug: Placebo + Doxycycline

• Registration Number: NCT05398055
• Lead Sponsor: Hospital General de Mexicali

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.

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-12
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-25
• Last Update Submitted: 2022-05-25
• Study First Posted: 2022-05-31
• Last Update Posted: 2022-05-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Azithromycin + Doxycycline	Azithromycine group
B	Placebo + Doxycycline	Placebo group

Primary Outcome Measures

Name	Time	Method
Mortality of azithromycin plus doxycycline vs doxycycline plus placebo	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital General de Mexicali; 🇲🇽 Mexicali, Baja California, Mexico