MalariaNCT00471666
Medical Implications of Coinfection With Malaria and Filariasis Parasites
An observational study of Malaria and Filariasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
This study will examine the clinical, immunological and epidemiological effects of concurrent infections with P. falciparum and W. bancrofti or M. perstans (the parasites that cause malaria and filariasis) on the frequency and severity of malaria infection in children and young adults in Mali, Africa. Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- Malaria, Filariasis
- How many people
- 1,039 participants
- Where
- 1 siteMali
- Study dates
- 7 May 2007to 31 Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1 - 20 years
- Male or non-pregnant female
- Resident of Tien gu bougou or Bougoudiana
- Age 1 - 20 years
- Male or non-pregnant female
- Resident of Tien gu bougou or Bougoudiana
Show all 10Show fewer
- Age > 10 years
- Male or non-pregnant female (by history)
- Resident of Tien gu bougou or Bougoudiana
- Willingness to allow storage of specimens for future research
Who cannot join
- History or clinical evidence of severe and/or chronic illness
- History of allergy to artesunate, amodiaquine, albendazole, praziquantel or mebendazole
- Plans to relocate outside the immediate vicinity of the village during the study period
- History or clinical evidence of severe and/or chronic illness
- History of allergy to artesunate, amodiaquine, albendazole, praziquantel or mebendazole
- Plans to relocate outside the immediate vicinity of the village during the study period
Show all 13Show fewer
- Hemoglobin less than or equal to 8 g/dL
- Symptoms of malaria with parasitemia greater than or equal to 100,000/microliters at enrollment
- Recent history or clinical evidence of prostration, bleeding, respiratory distress, seizures, coma or obtundation, jaundice, inability to drink, persistent vomiting
- History or clinical evidence of severe and/or chronic illness
- Hemoglobin less than or equal to g/dL
- Positive pregnancy test
- Clinical malaria (symptoms of malaria plus any malaria parasites identified on thick smear)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coinfection With Plasmodium Falciparum and Wuchereria Bancrofti: Clinical, Epidemiologic and Immunologic Implications
This study will examine the clinical, immunological and epidemiological effects of concurrent infections with P. falciparum and W. bancrofti or M. perstans (the parasites that cause malaria and filariasis) on the frequency and severity of malaria infection in children and young adults in Mali, Africa.
Residents of Tien gu bougou and Bougoudiana, Mali, who are between 1 and 20 years of age may be eligible for this study. Participants with and without filarial infection will be enrolled.
Read more
Participants undergo the following tests and procedures:
- Baseline evaluation with medical history and physical examination, blood tests and stool culture
- Brief physical examinations weekly
- Blood tests monthly for malaria
- Standard treatment offered for anyone with malaria
- Blood tests for filarial infection at the beginning, midpoint and end of the transmission season
- Treatment for lymphatic filariasis is available through the National Program for the Elimination of Lymphatic Filariasis. There is no effective standard therapy for M. perstans.
- Treatment for other parasitic worm infections, if needed.
Read the detailed description
Residents of malaria-endemic regions are frequently exposed to a variety of other parasites concurrently with malarial parasites. In Mali, lymphatic filariasis due to Wuchereria bancrofti co-exists in several regions highly endemic for malaria, and co-infection is common in the residents of these areas. Because of the chronicity of filarial infections and an associated bias towards the development of an adaptive immune response dominated by Th2 cytokines, a pre-existing filarial infection has the potential to alter the immune response towards incoming malarial parasites, clearance of which are considered to be dependent on a robust Th1 response. This could, in turn, affect the clinical manifestations and outcomes of malaria infection. Conversely, immune responses to filarial parasites may be modulated in the presence of malarial parasites. In addition to sharing a human host, Plasmodium falciparum and Wuchereria bancrofti are transmitted by the same mosquito vector, Anopheles gambiae, and interaction between the two species in the vector may have important implications for transmission of these two infections. The primary goals of this study are to determine the effect of concurrent infections with P. falciparum and W. bancrofti parasites on the prevalence and severity of malaria infection in children living in a Malian village co-endemic for two parasites and to assess the effects of co-infection on the immune responses to these two parasites over the course of the malaria transmission season. The epidemiology of co-infection at the human and vector level will also be examined.
- Conditions
- Malaria, Filariasis
- Keywords
- Malaria, Filariasis, Coinfection, Co-Infection
- Medical subject headings
- Malaria, Filariasis, Coinfection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study start7 May 2007
- Study completion31 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,039 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471666
- Sponsor's protocol ID
- 999907148
- Other IDs
- 07-I-N148
- Status last verified
- 31 Jan 2012
- First submitted
- 9 May 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Marsh K, Kinyanjui S. Immune effector mechanisms in malaria. Parasite Immunol. 2006 Jan-Feb;28(1-2):51-60. doi: 10.1111/j.1365-3024.2006.00808.x.
PubMed 16438676Breman JG, Egan A, Keusch GT. The intolerable burden of malaria: a new look at the numbers. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):iv-vii. doi: 10.4269/ajtmh.2001.64.iv. No abstract available.
PubMed 11425185Gupta S, Snow RW, Donnelly CA, Marsh K, Newbold C. Immunity to non-cerebral severe malaria is acquired after one or two infections. Nat Med. 1999 Mar;5(3):340-3. doi: 10.1038/6560.
PubMed 10086393
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coinfection With Plasmodium Falciparum and Wuchereria Bancrofti: Clinical, Epidemiologic and Immunologic Implications
- ClinicalTrials.gov ID
- NCT00471666
- Acronym / sponsor ID
- 999907148
- Conditions
- Malaria, Filariasis
- Keywords
- Malaria, Filariasis, Coinfection, Co-Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,039 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 7 May 2007
- Study completion
- 31 Jan 2012
- First posted
- 10 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the clinical, immunological and epidemiological effects of concurrent infections with P. falciparum and W. bancrofti or M. perstans (the parasites that cause malaria and filariasis) on the frequency and severity of malaria infection in children and young adults in Mali, Africa.
Residents of Tien gu bougou and Bougoudiana, Mali, who are between 1 and 20 years of age may be eligible for this study. Participants with and without filarial infection will be enrolled.
Participants undergo the following tests and procedures:
- Baseline evaluation with medical history and physical examination, blood tests and stool culture
- Brief physical examinations weekly
- Blood tests monthly for malaria
- Standard treatment offered for anyone with malaria
- Blood tests for filarial infection at the beginning, midpoint and end of the transmission season
- Treatment for lymphatic filariasis is available through the National Program for the Elimination of Lymphatic Filariasis. There is no effective standard therapy for M. perstans.
- Treatment for other parasitic worm infections, if needed.
Detailed description
Residents of malaria-endemic regions are frequently exposed to a variety of other parasites concurrently with malarial parasites. In Mali, lymphatic filariasis due to Wuchereria bancrofti co-exists in several regions highly endemic for malaria, and co-infection is common in the residents of these areas. Because of the chronicity of filarial infections and an associated bias towards the development of an adaptive immune response dominated by Th2 cytokines, a pre-existing filarial infection has the potential to alter the immune response towards incoming malarial parasites, clearance of which are considered to be dependent on a robust Th1 response. This could, in turn, affect the clinical manifestations and outcomes of malaria infection. Conversely, immune responses to filarial parasites may be modulated in the presence of malarial parasites. In addition to sharing a human host, Plasmodium falciparum and Wuchereria bancrofti are transmitted by the same mosquito vector, Anopheles gambiae, and interaction between the two species in the vector may have important implications for transmission of these two infections. The primary goals of this study are to determine the effect of concurrent infections with P. falciparum and W. bancrofti parasites on the prevalence and severity of malaria infection in children living in a Malian village co-endemic for two parasites and to assess the effects of co-infection on the immune responses to these two parasites over the course of the malaria transmission season. The epidemiology of co-infection at the human and vector level will also be examined.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Age 1 - 20 years
- Male or non-pregnant female
- Resident of Tien gu bougou or Bougoudiana
- Age 1 - 20 years
- Male or non-pregnant female
Key exclusion criteria (13 listed)
- History or clinical evidence of severe and/or chronic illness
- History of allergy to artesunate, amodiaquine, albendazole, praziquantel or mebendazole
- Plans to relocate outside the immediate vicinity of the village during the study period
- History or clinical evidence of severe and/or chronic illness
- History of allergy to artesunate, amodiaquine, albendazole, praziquantel or mebendazole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 16438676Marsh K, Kinyanjui S. Immune effector mechanisms in malaria. Parasite Immunol. 2006 Jan-Feb;28(1-2):51-60. doi: 10.1111/j.1365-3024.2006.00808.x.
- Background: PubMed 11425185Breman JG, Egan A, Keusch GT. The intolerable burden of malaria: a new look at the numbers. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):iv-vii. doi: 10.4269/ajtmh.2001.64.iv. No abstract available.
- Background: PubMed 10086393Gupta S, Snow RW, Donnelly CA, Marsh K, Newbold C. Immunity to non-cerebral severe malaria is acquired after one or two infections. Nat Med. 1999 Mar;5(3):340-3. doi: 10.1038/6560.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Filariasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00471666, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.