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

NCT05398055 | Unknown Phase 3

• 1 other identifier: 02-01//2022-05-09-066-20
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Rocky Mountain Spotted Fever

Keywords

Rocky Mountain Spotted Fever; Azithromycin; Doxycycline

Outcome Measures

Primary Outcomes (1)

• Mortality of azithromycin plus doxycycline vs doxycycline plus placebo

  3 years

Secondary Outcomes (4)

• 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

Study Arms (2)

A

EXPERIMENTAL

Azithromycine group

Drug: Azithromycin + Doxycycline

B

PLACEBO COMPARATOR

Placebo group

Drug: Placebo + Doxycycline

Interventions

Azithromycin + Doxycycline DRUG

azithromycin 500 mg orally every 24 hours for three dose plus doxycycline 100 mg orally every 12 hours for 7 days

Also known as: A

A

Placebo + Doxycycline DRUG

doxycycline 100 mg orally every 12 hours for 7 days plus placebo 1 capsule every 24 hours, 3 doses

Also known as: B

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital General de Mexicali: lead

Study Sites (1)

Hospital General de Mexicali

Mexicali, Estado de Baja California, 21000, Mexico

RECRUITING

MeSH Terms

Conditions

Rocky Mountain Spotted Fever

Interventions

Azithromycin; Doxycycline

Condition Hierarchy (Ancestors)

Spotted Fever Group Rickettsiosis; Rickettsia Infections; Rickettsiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Tick-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Hiram J Jaramillo-Ramirez, MD

  Hospital General de Mexicali

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiram J. Jaramillo-Ramirez, MD

CONTACT

686 135 8412; grupoinvestigacionmedica@gmail.com

Gisel V. Licon-Martinez, MD

CONTACT

686 194 5903; viviana.licon@uabc.edu.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: Controlled randomized trial with placebo, triple blinded, multicenter study

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 31, 2022
• Study Start: May 12, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

ME (1)