Clinical trial NCT05398055: Efficacy of Azithromycin Plus Doxycycline Versus Doxycycline Plus Placebo in Patients With Rocky Mountain Spotted Fever
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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rocky Mountain Spotted Fever
Keywords: Rocky Mountain Spotted Fever
Azithromycin
Doxycycline
Lead sponsor: Hospital General de Mexicali
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled randomized trial with placebo, triple blinded, multicenter study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mortality of azithromycin plus doxycycline vs doxycycline plus placebo
timeFrame: 3 years
Secondary outcomes:
measure: Number of hospitalization days in each arm
timeFrame: 3 years
measure: Number of participants with renal replacement therapy.
timeFrame: 3 years
measure: Number of participants that required amines in both groups.
timeFrame: 3 years
measure: Number of fever days in both arms.
timeFrame: 3 years
Other outcomes:
Locations:
city: Mexicali
country: Mexico
facility: Hospital General de Mexicali
state: Baja California
Study officials:
affiliation: Hospital General de Mexicali
name: Hiram J Jaramillo-Ramirez, MD
role: PRINCIPAL_INVESTIGATOR
References: