Erythema Migrans in Elderly

NCT03371563 | Completed

• 1 other identifier: EM-elderly
• Study Type: observational
• Target: 1,220
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators will focus on elderly patients with early Lyme borreliosis with the aim of assessing clinical course, serological response and treatment outcome of the disease as compared to younger adults. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of Lyme borreliosis.

Conditions

Lyme Disease; Erythema Migrans; Elderly Infection

Outcome Measures

Primary Outcomes (4)

• Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days postenrollment in patients treated for erythema migrans

  At follow-up at 14 days patients were examined physically and were asked an open question about health-related symptoms. Symptoms that had newly develop or worsened since the onset of the multiple erythema migrans and which will had no other known medical explanation were regarded as post-Lyme symptoms. Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis was interpreted as failure.

  Study point: at 14 days post-enrollment.

• Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months postenrollment in patients treated for erythema migrans with doxycycline for 7 or 14 days

  At follow-up at 2 months patients were examined physically and were asked an open question about health-related symptoms. Symptoms that hed newly develop or worsened since the onset of the erythema migrans and which will had no other known medical explanation were regarded as post-Lyme symptoms. Complete response to treatment was defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/ or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment was be interpreted as failure.

  Study point: at 2 months post-enrollment.

• Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months postenrollment in patients treated for erythema migrans

  At follow-up at 6 months patients were examined physically and were asked an open question about health-related symptoms. Symptoms that had newly develop or worsened since the onset of the erythema migrans and which had no other known medical explanation were regarded as post-Lyme symptoms. Complete response to treatment was defined as a return to pre-Lyme health status. Partial response was defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/ or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment was interpreted as failure.

  Study point: at 6 months post-enrollment.

• Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months postenrollment in patients treated for erythema migrans

  At 12 months patients were examined physically and were asked an open question about health-related symptoms. Symptoms that had develop or worsened since the onset of the erythema migrans and which had no other known medical explanation were regarded as post-Lyme symptoms. Complete response to treatment was defined as a return to pre-Lyme health status. Partial response was defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/ or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment was interpreted as failure.

  Study point: at 12 months post-enrollment.

Secondary Outcomes (1)

• Change in occurrence of nonspecific symptoms from baseline to 6 months and to 12 months post-enrollment in patients with erythema migrans and control subjects

  Study points will be: at enrollment, at 6, and at 12 months post-enrollment

Study Arms (4)

elderly patients

Drug: Antibiotics

middle-aged patients

Drug: Antibiotics

controls

Other: no intervention

young patients

Drug: Antibiotics

Interventions

Antibiotics DRUG

Patients were treated with antibiotics for Lyme disease.

elderly patients; middle-aged patients; young patients

no intervention OTHER

controls were not given antibiotics

controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

young (18-44 years), middle-aged (45-64 years) and elderly 65 or more years) patients with erythema migrans

You may qualify if:

• erythema migrans

You may not qualify if:

• pregnancy or lactation
• immunocompromised
• taking antibiotic with antiborrelial activity within 10 days
• received \<10 days of antibiotic therapy for erythema migrans
• had an intercurrent episode of Lyme borreliosis during follow-up

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

MeSH Terms

Conditions

Lyme Disease; Glossitis, Benign Migratory

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Glossitis; Tongue Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: January 1, 2006
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 23, 2019

Record last verified: 2019-04