Loa Loa Clinical Trial
Official title:
Comparison Between the Post-Treatment Reactions After Single-dose Ivermectin or DEC in Subjects With Loa Loa Infection
Background:
- 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.
Objectives:
- To study the side effects of DEC and ivermectin treatment for Loa loa infection.
Eligibility:
- 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.
Design:
- 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.
Status | Completed |
Enrollment | 300 |
Est. completion date | January 2014 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 60 Years |
Eligibility |
- INCLUSION CRITERIA (SCREENING): A subject will be eligible for participation in the screening portion of this protocol if all of the following criteria apply: 1. male or non-pregnant and not breastfeeding female subjects, 2. age 20-60 years (per participant self-report) 3. resident of Akonolinga 4. Loa microfilaremia from 20 to 5000 mf/mL from the prior screening in the village or did not participate in the prior screening 5. consent to a blood draw to screen for infection with Loa loa 6. must be willing to have blood samples stored EXCLUSION CRITERIA (SCREENING): A subject will not be eligible for participation in the screening portion of this study if any of the following conditions apply: 1. Known to be pregnant (by history) or breastfeeding 2. Chronic medical conditions, including but not limited to diabetes, renal or hepatic insufficiency, immunodeficiency, psychiatric disorder, seizure, that in the investigators judgments are deemed to be clinically significant 3. History of hypersensitivity reaction to DEC or IVM INCLUSION CRITERIA (INTERVENTIONAL STUDY): A subject will be eligible for participation in the interventional portion of the study only if all of the following additional inclusion criteria apply: 1. Loa loa microfilaremia between 20 and 2,000 mf/mL blood drawn between 11:30 am and 2:30 pm measured within 30 days prior to the baseline visit 2. The subject agrees to storage of samples for study EXCLUSION CRITERIA (INTERVENTIONAL STUDY): A subject will not be eligible to participate in the interventional portion of the study if any of the following conditions are fulfilled at the time of enrollment: 1. Pregnancy (by serum or urine beta-HCG) or breastfeeding 2. Chronic kidney or liver disease 3. Hgb < 10 gm/dL 4. Filarial infection other than Loa loa or M. perstans (O. volvulus, or W. bancrofti) 5. Use of DEC or IVM within the past 6 months 6. Use of immunosuppressive therapies, including steroids, within the past month 7. Any condition that in the investigator s opinion places the subject at undue risk by participating in the study EXCLUSION OF CHILDREN AND PREGNANT WOMEN: Pregnant women and children (the age of consent in Cameroon is 20 years of age) will be excluded from this study since it involves administration of medications contraindicated in pregnancy and more than minimal risk with no prospect of direct benefit, respectively. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Cameroon | Filariasis and other Tropical Diseases Research Center | Yaounde |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
Cameroon,
Boussinesq M. Loiasis. Ann Trop Med Parasitol. 2006 Dec;100(8):715-31. Review. — View Citation
Klion AD, Massougbodji A, Sadeler BC, Ottesen EA, Nutman TB. Loiasis in endemic and nonendemic populations: immunologically mediated differences in clinical presentation. J Infect Dis. 1991 Jun;163(6):1318-25. — View Citation
Winkler S, Paiha S, Winkler H, Graninger W, Marberger M, Steiner GE. Microfilarial clearance in loiasis involves elevation of Th1 and Th2 products and emergence of a specific pattern of T-cell populations. Parasite Immunol. 1996 Sep;18(9):479-82. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The peak % change from baseline eosinophil count measured during the first 7 days post-treatment. | 7 days | No | |
Secondary | The frequency and severity of adverse events | 7 days | Yes | |
Secondary | Markers of eosinophil activation, including levels of surface marker expression on eosinophils and serum levels of eosinophil granule proteins | 7 days | No | |
Secondary | Proportion of subjects who clear microfilaremia | 14 days | No |