Ignite Creation Date:
2024-05-06 @ 12:31 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01593722
Status:
COMPLETED
Last Update Posted:
2016-11-09
First Post:
2012-05-05
Brief Title:
Post-treatment Effects of Ivermectin IVM or Diethylcarbamazine DEC in Loiasis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Comparison Between the Post-Treatment Reactions After Single-dose Ivermectin or DEC in Subjects With Loa Loa Infection
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Ivermectin is currently used for mass drug distribution for the control of onchocerciasis and elimination of lymphatic filariasis in Africa Due to the occurrence of severe neurologic adverse events in individuals with concomitant Loa loa infection and high levels of circulating microfilariae drug distribution has been halted in many areas in Cameroon Democratic Republic of Congo and other Loa-endemic countries Diethylcarbamazine citrate DEC is the treatment of choice for Loa loa infection in the United States and other non-endemic countries but can also be associated with the development of severe adverse reactions including fatal encephalopathy that are correlated with the number of circulating microfilariae in the blood The cause of these reactions is unknown and it is not known if post-treatment reactions to DEC and ivermectin both have the same underlying mechanism Post-treatment reactions to both medications are accompanied by a dramatic interleukin-5 IL-5-dependent increase in eosinophilia and evidence of eosinophil activation Preliminary data suggests that unlike post-treatment responses in Wolbachia-containing filariae inflammatory mediators commonly seen in bacterial infections and malaria including tumor necrosis factor TNF-alpha and IL-1-beta are not increased post-treatment with DEC The aim of this study is to characterize the immunologic mechanisms of ivermectin and DEC posttreatment reactions so that it can be established whether or not these posttreatment reactions have the same underlying mechanism An understanding of the pathophysiology of these post-treatment reactions is necessary in order to develop strategies to prevent these reactions in the future We plan to randomize 20 subjects with low- to- moderate numbers of circulating Loa loa microfilariae to receive a single oral dose of either ivermectin 200 mcgkg or DEC 8 mgkg in an inpatient setting in Cameroon Signs and symptoms blood microfilarial levels complete blood counts intracellular and serum cytokine levels and markers of eosinophil activation will be assessed at baseline 4 and 8 hours and 1 2 3 5 7 and 9 and 14 days post-treatment and compared between the two treatment groups Subjects who received ivermectin will be treated with single dose DEC 8 mgkg on day 14 All subjects will then be followed at 6 and 12 months post-hospitalization to determine whether they have experienced Loa-specific symptoms eyeworm or Calabar swellings Mf count and complete blood count CBC with differential will be obtained at each follow-up visit Subjects with Loa-specific symptoms or mf counts 100 mfmL at the 6 month time point will be offered a full treatment course If 50 of subjects meet criteria for full DEC treatment at the 6 month time point all subjects will be treated and the study will enter a follow-up phase with a visit at 12 months 6 months after the full treatment course
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12-I-N117 | OTHER | NIAID IRB | None |