Post-Treatment Side Effects of Ivermectin or DEC for Loa Loa Infection
- Loa loa is a small worm that infects people in West and Central Africa. It is spread by the bite of a fly. Adult worms live under the skin and can cause swelling in the arms, legs, and face. Some people have more serious infections in the heart, kidneys, or brain. Most people with Loa loa infection have no symptoms at all. The standard treatment for Loa loa infection is a medicine called diethylcarbamazine (DEC). Some people have bad reactions to DEC, including itching, muscle pains, and in severe cases coma and death.
- Another drug, ivermectin, is used in mass drug treatment programs to prevent the spread of worm infections that cause blindness and massive swelling (elephantiasis). However, people who also have Loa loa have had serious bad reactions to ivermectin. Researchers want to study both DEC and ivermectin to find out why these reactions occur. If they can be prevented, mass drug treatment programs will be able to be used in areas in Africa where Loa loa exists.
- To study the side effects of DEC and ivermectin treatment for Loa loa infection.
- Individuals who live in 4 villages in Cameroon where Loa loa infection is known to exist, who are between 20 and 60 years of age, not pregnant or breastfeeding and have a low level of Loa loa parasites in the blood, but are otherwise healthy.
- Participants will be screened with a physical exam and medical history. Blood samples will be collected to check for Loa loa infection. Participants will also have an eye exam and provide skin samples to check for other worm infections that may interfere with the study treatment.
- Participants will be admitted to the hospital for 4 days (during and after the treatment). They will receive a single dose of either DEC or ivermectin.
- After treatment, regular blood samples will be collected. Participants will be asked questions about how they feel after treatment. Physical exams will be performed. If side effects develop, participants will be treated at the hospital.
- After leaving the hospital, participants will have followup visits. These visits will happen on days 5, 7, 9, and 14 after receiving the study medicine. They will involve a short physical exam and collection of blood samples.
- At the end of the study, participants will be offered a full 21-day DEC treatment to cure the Loa loa infection.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Comparison Between the Post-Treatment Reactions After Single-dose Ivermectin or DEC in Subjects With Loa Loa Infection|
- The peak % change from baseline eosinophil count measured during the first 7 days post-treatment. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- The frequency and severity of adverse events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- Markers of eosinophil activation, including levels of surface marker expression on eosinophils and serum levels of eosinophil granule proteins [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Proportion of subjects who clear microfilaremia [ Time Frame: 14 days ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Study Completion Date:||January 2014|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593722
|Filariasis and other Tropical Diseases Research Center|
|Principal Investigator:||Amy D Klion, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|